An Open-Label Phase III Clinical Trial to Study the Immunogenicity and Tolerability of GARDASIL®9 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Adult Women (27- to 45-Year-Olds) Compared to Young Adult Women (16-to-26 Year-Olds)

Start Date22 Jun 2016

Sponsor / Collaborator

Sanofi Pasteur MSD SNC

EUCTR2013-003399-10-DE / Not yet recruitingNot Applicable

A Randomized, Double-Blinded, Controlled with GARDASIL® (Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)), Phase 3 Clinical Trial to Study the Immunogenicity and Tolerability of V503 (9-Valent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in 16- to 26-year-old men.

Start Date24 Mar 2014

Sponsor / Collaborator

Sanofi Pasteur MSD SNC

EUCTR2010-021491-28-SE / Not yet recruitingNot Applicable

A phase III randomized, double-blind, active-comparator controlled clinical trial to study the safety, tolerability, and immunogenicity of V419 in healthy infants when given at 2, 4, and 11 to 12 months

Start Date09 Aug 2011

Sponsor / Collaborator

Sanofi Pasteur MSD SNC

100 Clinical Results associated with Sanofi Pasteur MSD SNC

0 Patents (Medical) associated with Sanofi Pasteur MSD SNC

Literatures (Medical) associated with Sanofi Pasteur MSD SNC

01 Jul 2016·VaccineQ3 · MEDICINE

The predicted persistence and kinetics of antibody decline 9 years after pre-school booster vaccination in UK children

Q3 · MEDICINE

Article

Author: Yu, Ly-Mee ; Thomas, Stéphane ; Kandasamy, Rama ; Baudin, Martine ; Voysey, Merryn ; Pollard, Andrew J ; John, Tessa ; Sadorge, Christine

BACKGROUNDLong term follow-up of vaccine trials is essential to establish the duration of protection. In the context of worldwide concern about rising pertussis incidence, estimates of antibody persistence after vaccination, which do not account for the rise in antibody due to natural boosting or infection, may overestimate the degree of protection afforded by pertussis vaccines.METHODSThis was a 5year follow up study of a randomised controlled trial of diphtheria, tetanus, pertussis and polio booster vaccines in UK children aged 3.5-5years. Antibody persistence was measured at 1month, 1, 3, and 5years after vaccination and the kinetics of antibody decline were modelled longitudinally. Estimates of predicted antibody persistence 9years after the pre-school booster were derived from model parameters.RESULTSAntibody levels 9years after vaccination were predicted to be above accepted thresholds for protection for diphtheria, tetanus and polio. Antibody responses to pertussis toxoid were undetectable in 49% of children at the 5year follow up visit, and responses were predicted to be undetectable in 69% (95% CI 45-88%) of children by the time of their teenage booster at 13-14years of age.CONCLUSIONSThere is no defined correlate of protection for pertussis. However, the large proportion of participants in this study with undetectable pertussis antibody levels at both measured and predicted timepoints suggests sub-optimal immunity in adolescence. Adding pertussis to the teenage booster for UK children as is done in other countries, would enhance immunity in adolescence.

01 Aug 2015·VaccineQ3 · MEDICINE

Immunogenicity of a low-dose diphtheria, tetanus and acellular pertussis combination vaccine with either inactivated or oral polio vaccine compared to standard-dose diphtheria, tetanus, acellular pertussis when used as a pre-school booster in UK children: A 5-year follow-up of a randomised controlled study

Q3 · MEDICINE

Article

Author: McCarthy, N ; Kitchin, N ; Yu, L M ; Pollard, A J ; Baudin, M ; John, T ; Fiquet, A ; Voysey, M ; Richard, P

This serological follow up study assessed the kinetics of antibody response in children who previously participated in a single centre, open-label, randomised controlled trial of low-dose compared to standard-dose diphtheria booster preschool vaccinations in the United Kingdom (UK). Children had previously been randomised to receive one of three combination vaccines: either a combined adsorbed tetanus, low-dose diphtheria, 5-component acellular pertussis and inactivated polio vaccine (IPV) (Tdap-IPV, Repevax(®); Sanofi Pasteur MSD); a combined adsorbed tetanus, low-dose diphtheria and 5-component acellular pertussis vaccine (Tdap, Covaxis(®); Sanofi Pasteur MSD) given concomitantly with oral polio vaccine (OPV); or a combined adsorbed standard-dose diphtheria, tetanus, 2-component acellular pertussis and IPV (DTap-IPV, Tetravac(®); Sanofi Pasteur MSD). Blood samples for the follow-up study were taken at 1, 3 and 5 years after participation in the original trial (median, 5.07 years of age at year 1), and antibody persistence to each vaccine antigen measured against defined serological thresholds of protection. All participants had evidence of immunity to diphtheria with antitoxin concentrations greater than 0.01IU/mL five years after booster vaccination and 75%, 67% and 79% of children who received Tdap-IPV, Tdap+OPV and DTap-IPV, respectively, had protective antitoxin levels greater than 0.1IU/mL. Long lasting protective immune responses to tetanus and polio antigens were also observed in all groups, though polio responses were lower in the sera of those who received OPV. Low-dose diphtheria vaccines provided comparable protection to the standard-dose vaccine and are suitable for use for pre-school booster vaccination.

01 May 2011·Clinical and Vaccine Immunology

Results from a Randomized Clinical Trial of Coadministration of RotaTeq, a Pentavalent Rotavirus Vaccine, and NeisVac-C, a Meningococcal Serogroup C Conjugate Vaccine

Article

Author: Karvonen, Aino ; Fiquet, Anne ; Thomas, Stéphane ; Kitchin, Nick ; Vesikari, Timo ; Borrow, Ray ; Baudin, Martine

ABSTRACT RotaTeq (Merck & Co. Inc./Sanofi Pasteur MSD) is a three-dose, oral pentavalent rotavirus vaccine for the immunization of infants from 6 weeks of age for the prevention of rotavirus gastroenteritis. The primary objective of the present trial was to demonstrate that RotaTeq can be coadministered with meningococcal serogroup C conjugate vaccine (MenCC; NeisVac-C; Baxter Healthcare) to healthy infants without impairing the protective immune responses to MenCC. This was an open-label, randomized, comparative study conducted in Finland. The study was designed to assess concomitant versus sequential administration of RotaTeq and MenCC on the immune response to both vaccines. Healthy infants ( n = 247), aged 6 to 7 weeks, were recruited. Coadministration of MenCC with RotaTeq was noninferior to sequential administration for the seroprotection rate against meningococcal serogroup C (the proportion of infants with a serum bactericidal antibody titer using baby rabbit complement of ≥8 was 100% in both groups). The other responses to MenCC (titer of ≥1:128, ≥4-fold increase in titer, and geometric mean titers [GMTs]) and the responses to RotaTeq (IgA and SNA response to G1 to G4 and P1A[8], GMTs, and ≥3-fold increase in titer) were comparable between groups, including a ≥3-fold IgA increase in >96% of the infants in both groups. Concomitant administration of the first doses of MenCC, diphtheria and tetanus toxoids and acellular pertussis vaccine, inactivated poliovirus vaccine, and Haemophilus influenzae type b conjugate vaccine (DTaP-IPV-Hib), and RotaTeq was associated with a higher rate of vomiting and diarrhea than concomitant administration of MenCC and DTaP-IPV-Hib, but that was not observed after the second concomitant administration. The convenience of concomitant administration of RotaTeq and MenCC may, however, outweigh the additive effect of mostly mild adverse events reported after the individual administration of each vaccine. These results support the coadministration of RotaTeq and MenCC.

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Drug(Targets)	Indications	Global Highest Phase

Haemophilus B conjugate (meningococcal protein conjugate) and hepatitis B (recombinant) vaccine(Sanofi Pasteur SA)	Hepatitis B More	Withdrawn
diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis, hepatitis B (recombinant) and Haemophilus influenzae type b conjugate vaccine, adjuvanted	Haemophilus Infections More	Withdrawn

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