Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in India and the Republic of South Africa

This open label randomized study will be conducted to evaluate and/or describe the immunogenicity and describe the safety of MenACYW conjugate vaccine when administered in infants and toddlers.
It will be conducted in India and the RSA in 2 cohorts:
Cohort I: Infants and toddlers 6 months to 16 months of age
Cohort II: Infants and toddlers 6 weeks to 15 months of age
In Cohort I, eligible participants will be randomized in a 1:1 ratio to receive 2 intramuscular (IM) injections (1+1 vaccination schedule) of either MenACYW conjugate vaccine (Groups 1 and 3) or Menactra vaccine (Groups 2 and 4), co-administered with routine pediatric vaccines.
In Cohort II, eligible participants will be randomized in a 2:1 ratio to receive either 3 IM injections (2+1 vaccination schedule) of MenACYW conjugate vaccine co-administered with routine pediatric vaccines (Groups 5 and 7) or routine pediatric vaccines only (Groups 6 and 8).
The primary objectives of this study are:
To demonstrate the non-inferiority of immunogenicity of 2 doses of MenACYW conjugate vaccine compared to 2 doses of Menactra® vaccine in infants and toddlers 6 months to 16 months of age in terms of serum bactericidal assay using human complement (hSBA) seroprotection (titers ≥ 1:8) in India and the Republic of South Africa (RSA)
To demonstrate the vaccine immune sufficiency of 3 doses of MenACYW conjugate vaccine in infants and toddlers 6 weeks to 15 months of age in terms of hSBA seroprotection (titers ≥ 1:8) in India and the RSA
The secondary objectives of this study are:
To describe the antibody titers to the meningococcal serogroups A, C, Y, and W:
before and 30 days post primary series of MenACYW conjugate vaccine and before and 30 days post booster dose of MenACYW conjugate vaccine in infants and toddlers 6 weeks to 15 months of age in India and the RSA when administered concomitantly with other age-recommended vaccines.
before and after 30 days post each dose of MenACYW conjugate vaccine or Menactra vaccine in infants and toddlers 6 months to 16 months of age in India and the RSA when administered concomitantly with other age-recommended vaccines.
To describe the antibody responses against the antigens of the other age-recommended vaccines when administered concomitantly with MenACYW conjugate vaccine:
in infants and toddlers 6 weeks to 15 months of age in India and the RSA.
in infants and toddlers 6 months to 16 months of age in India and the RSA. The duration of each participant's active participation in the study will be approximately 10 to 11 months for Cohort I and 13,5 to 14,5 months for Cohort II.

Start Date27 Mar 2023

Sponsor / Collaborator

Sanofi Pasteur

NCT04143061 / CompletedPhase 3

Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Adults, Adolescents, Children, and Toddlers in India and Healthy Adolescents and Children in the Republic of South Africa

This will be a Phase III, modified double-blind (open-label for toddlers in India), randomized, parallel-group, active-controlled, step-wise, multi-center study to compare and describe the immunogenicity and safety of MenACYW conjugate vaccine when administered as a single dose in healthy adults, adolescents, children, and toddlers in India and a modified double-blind, randomized, parallel-group, active-controlled, multi-center study to compare and describe the immunogenicity and safety of MenACYW conjugate vaccine when administered as a single dose in healthy adolescents and children in the Republic of South Africa (RSA).

Start Date30 Dec 2019

Sponsor / Collaborator

Sanofi Pasteur

NCT03917654 / CompletedPhase 2IIT

Safety, Immunogenicity and Efficacy of Pfs230D1M-EPA/AS01 Vaccine, a Transmission Blocking Vaccine Against Plasmodium Falciparum, in an Age De-Escalation Trial of Children and a Family Compound Trial in Mali

Background:
Malaria affects many people in Mali and other parts of Africa. It is spread by mosquito bites. Malaria can make people sick or can lead to death. Scientists want to learn if a vaccine can stop it from spreading to other people.
Objective:
To test how well an experimental malaria vaccine works to decrease malaria infections.
Eligibility:
Healthy people ages 5 and older who live in Doneguebougou, Mali, and surrounding areas
Design:
Participants will be screened with:
Medical history
Physical exam
Blood, urine, and heart tests
EKG
Participants will be randomly assigned to get either the experimental vaccine or an approved vaccine. They will not know which they are getting.
Participants will have a visit about a week before their first vaccine. They will take a medicine that kills malaria. They will take it at the clinic the next 2 days. Participants ages 5-8 will take the drug again 2 weeks before their third vaccine.
Participants get the vaccine through a needle in the arm. They will have visits 1, 3, 7, and 14 days after. They will have blood tests or finger pricks.
Participants will get another vaccine 1 and 6 months later.
Participants will have blood tests once a month. At these visits they may also have urines tests or mosquito feeds. For the feeds a cup full of mosquitoes will be placed on arms or legs for 15-20 minutes.
Participants will have visits twice a month for 4 months after their last vaccine.

Start Date24 Apr 2019

Sponsor / Collaborator

National Institute of Allergy & Infectious Diseases

100 Clinical Results associated with Inactivated hepatitis A vaccine(Sanofi)

100 Translational Medicine associated with Inactivated hepatitis A vaccine(Sanofi)

100 Patents (Medical) associated with Inactivated hepatitis A vaccine(Sanofi)

Literatures (Medical) associated with Inactivated hepatitis A vaccine(Sanofi)

19 Jul 2023·Vaccine

Delaying the third dose of Japanese aluminum-free hepatitis A vaccine Aimmugen elicits effective immune responses against hepatitis A in adults.

Article

Author: Fukushima, Shinji ; Hamada, Atsuo ; Tada, Yuki ; Nakano, Takashi ; Kiyohara, Tomoko

Inactivated aluminum-adsorbed hepatitis A vaccines such as Havrix, Vaqta, and Avaxim are commonly used worldwide. These vaccines are typically administered in a two-dose series (at 0 and 6-12 months). However, a lyophilized inactivated aluminum-free hepatitis A vaccine, Aimmugen, which is approved in Japan, is typically administered in a three-dose series (at 0, 2-4, and 24 weeks). Hence, individuals visiting endemic hepatitis A areas receive the primary two doses of Aimmugen before traveling and the third booster dose much later. It is currently uncertain whether boosting with a delayed third dose of Aimmugen is effective, or whether a new vaccination schedule should instead be initiated. Therefore, we investigated the anti-hepatitis-A viral immune response of adult travelers who received the third dose of Aimmugen more than 24 weeks after the first dose. Participants were vaccinated with the third dose of Aimmugen more than 2 years after the first two doses. Antibody titers were measured at Day 0 (prevaccination) and at 28-42 days after the third dose of Aimmugen. Twenty-nine adult participants were enrolled in the study (14 men and 15 women; mean age ± standard deviation age, 36.2 ± 8.1 years). The interval between the first two doses and the third dose was 3-14 years. The seroprotection rate (i.e., the percentage of participants with anti-hepatitis A virus antibody titers ≥ 10 mIU/mL) was 96.6 % (28/29) at Day 0 and increased to 100 % (29/29) at Days 28-42. Geometric mean concentration increased from 105 to 4,013 mIU/mL. We demonstrated that delaying the third dose of Aimmugen still elicited effective immune responses after priming with two doses of the vaccine. Trial registration: UMIN Clinical Trials Registry (UMIN-CTR): MIN000013624. Registered 03 April 2014. https://center6.umin.ac.jp/cgi-bin/ctr/ctr_view_reg.cgi?recptno=R000015906.

01 Jun 2022·Sexually Transmitted DiseasesQ3 · MEDICINE

Protection to Self and to One's Sexual Partner After Human Papillomavirus Vaccination: Preliminary Analysis From the Transmission Reduction And Prevention with HPV Vaccination Study

Q3 · MEDICINE

Article

Author: MacCosham, Aaron ; Tellier, Pierre-Paul ; Franco, Eduardo L. ; Coutlee, Francois ; Burchell, Ann N. ; El-Zein, Mariam

Background:

It is unknown whether recently human papillomavirus (HPV)–vaccinated individuals confer protection against vaccine-preventable HPV types to their partners.

Methods:

Participants 18 to 45 years old who were living in Montreal, Canada, and in a heterosexual relationship of 6 months or less were randomly assigned to receive the intervention HPV vaccine, Gardasil or Gardasil 9, or active control (AC), Avaxim, a hepatitis A vaccine. Couples attended a maximum of 6 clinic visits (baseline and at 2, 4, 6, 9, and 12 months) and provided genital samples for detection of 36 HPV genotypes. Participants were vaccinated at baseline and at 2 and 6 months. We used Cox proportional hazards regression models to estimate hazard ratios (HRs) and 95% confidence intervals (CIs) for associations between the administered vaccine and infections at the HPV episode level.

Results:

We restricted analyses to 273 participants (intervention: n = 141, AC: n = 132) who had at least 2 visits with valid HPV data. The HR of becoming positive for a given vaccine-preventable HPV type in the intervention group among those who received at least 1 dose compared with AC was 0.47 (95% CI, 0.23–0.97). Comparing individuals with HPV-vaccinated versus AC-vaccinated partners, there was no difference in risk of becoming positive for a given vaccine-preventable HPV type among those whose partners received at least 1 (HR, 1.46; 95% CI, 0.73–2.94) or 2 (HR, 0.78; 95% CI, 0.31–1.96) doses.

Conclusions:

Our study provides inconclusive evidence that individuals whose partner recently received an HPV vaccine are protected from vaccine-preventable types but demonstrates that vaccinated individuals are at a lower risk of incident infections.Trial Registration Number: NCT01824537.

01 Aug 2020·BMJ openQ4 · MEDICINE

Transmission reduction and prevention with HPV vaccination (TRAP-HPV) study protocol: a randomised controlled trial of the efficacy of HPV vaccination in preventing transmission of HPV infection in heterosexual couples

Q4 · MEDICINE

ArticleOA

Author: Burchell, Ann N ; MacCosham, Aaron ; Franco, Eduardo L ; Tellier, Pierre-Paul ; Coutlée, François ; El-Zein, Mariam

Introduction:

Human papillomavirus (HPV) is a causal agent of malignancies including cervical, vulvar, vaginal, penile, anal and oropharyngeal cancer, as well as benign conditions such as anogenital warts. HPV vaccination protects individuals against infections with the target HPV types and their clinical outcomes. However, little is known about the protection an immunised individual confers to their sexual partner or its impact on HPV transmission dynamics. In this context, the Transmission Reduction and Prevention with HPV vaccination (TRAP-HPV) study was designed to determine the efficacy of an HPV vaccine in reducing transmission of genital and oral HPV infection in sexual partners of vaccinated individuals.

Methods and analysis:

The TRAP-HPV study is an ongoing randomised controlled trial among heterosexual couples living in Montreal, Canada. Sexually active couples, aged between 18 and 45 years, who have been in a relationship no longer than 6 months are considered eligible. Participants are independently randomised to receive either the intervention HPV vaccine, Gardasil 9, or a placebo hepatitis A vaccine, Avaxim, creating four vaccination groups among couples: intervention–intervention, intervention–placebo, placebo–intervention and the placebo–placebo. Participants provide genital (vaginal/penile) and oral samples at baseline and five follow-up visits over a 1-year duration. Linear Array HPV genotyping is used to detect 36 HPV types. Cox proportional hazard regression models will be used to estimate the effect of vaccination on HPV transmission.

Ethics and dissemination:

The TRAP-HPV study received ethical approval by institutional review boards McGill University, Concordia University and Centre Hospitalier de l’Université de Montréal. Before enrolment, all participants provide informed written consent. Results will be published in peer-reviewed journals and presented at national and international conferences. The generated empirical evidence could be used in mathematical models of vaccination to inform policymakers in Canada and elsewhere.

Trial registration number:

NCT01824537.

News (Medical) associated with Inactivated hepatitis A vaccine(Sanofi)

25 Apr 2023

·www.businesswire.com

Sanofi Announces Launch of AVAXIM® Junior in the UK for Active Immunisation Against Infection Caused by the Hepatitis A Virus in Children Aged 12 Months to 15 Years

READING, England--( BUSINESS WIRE )--Sanofi (EURONEXT: SAN and NASDAQ: SNY) has today announced the launch of AVAXIM ® Junior in the UK, an inactive hepatitis A vaccine indicated for use in children aged 12 months to 15 years inclusive to prevent infection caused by the hepatitis A virus. 1 The vaccination schedule consists of two vaccine doses injected by the intramuscular route 6 months to 36 months apart but can be given up to 7 years apart. 1 This launch was based on data from 20 clinical studies in 14 countries across Europe, the Middle East, Asia and the Americas, involving more than 6,200 children aged 12 months to 15 years who have received at least one dose of the vaccine in the context of a clinical trial. 2 The data show that AVAXIM Junior is effective in inducing a protective antibody response within two weeks in over 95% of individuals, and in nearly 100% before the booster dose administered six months after the first dose. 3 Rebecca Catterick, UK and Ireland Sanofi Vaccines General Manager , said: “Hepatitis A is one of the most prevalent travel-related vaccine-preventable diseases, so the availability of effective options like AVAXIM Junior will offer parents peace of mind knowing that they can help protect their children when travelling to high-risk areas.” Hepatitis A is one of the most common vaccine-preventable, viral infections worldwide Hepatitis A, caused by the hepatitis A virus, is primarily transmitted through contaminated food and water or by direct contact with an infectious person. 4 Incidence of the disease is closely related to socio-economic conditions, so it is most prevalent in developing countries with poor sanitary conditions and hygiene practices. 4,5 It is the most common form of viral hepatitis 6 and the third most common vaccine-preventable infection among travelers. 7 ENDS About AVAXIM ® 80U Paediatric AVAXIM Junior is indicated for active immunisation against infection caused by the hepatitis A virus in children aged 12 months to 15 years inclusive. It can be used for both primary and booster vaccination and should be given according to official recommendations. 1 Most commonly observed side effects include pain at the injection site, a general feeling of discomfort or being unwell (malaise), headache and abnormal crying. 1,3 Most reactions were limited to the first few days following vaccination with spontaneous recovery. 1,3 AVAXIM Junior is a ready-to-use suspension for injection containing 80 antigen units of inactivated hepatitis A virus and is available in 0.5ml unidoses of suspension in pre-filled syringes with attached needles. 1 About Sanofi We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and potentially life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the centre of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY References 1 AVAXIM Junior SmPC. May 2021 2 Sanofi Pasteur. Data on file. March 2017 3 Sanofi Pasteur. Avaxim®80U Pediatric. Clinical Core Data Sheet. 195- Pediatric Hepatitis A vaccine - CCDS – version 15 –24 September 2020 4 WHO. WHO position paper on Hepatitis A vaccines – June 2012. Wkly Epidemiol Rec, 2012;87(28/29):261-76. 5 WHO. Health Emergency and Disaster Risk Management Fact Sheets. WATER, SANITATION AND Hygiene. December 2017. Available at: https://cdn.who.int/media/docs/default-source/disaster-mngmt/risk-management-wash-december2017.pdf?sfvrsn=81ddcc1a_1&download=true [Accessed January 2023]. 6 Luxemburger C, Dutta AK. Overlapping epidemiologies of hepatitis A and typhoid fever: the needs of the traveler. J Travel Med. 2005 Apr;12 Suppl 1:S12-21. 7 Steffen R, Behrens RH, Hill DR, Greenaway C, Leder K. Vaccine-preventable travel health risks: what is the evidence—what are the gaps? J Travel Med. 2015;22(1):1-12. Job Code: MAT-XU-2300110 (V1.0) Date of Preparation: April 2023

Vaccine

100 Deals associated with Inactivated hepatitis A vaccine(Sanofi)

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Hepatitis A	GB	Sanofi	01 Jun 1996

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