Delving into the Latest Updates on DTwP-Hib vaccine (Serum Institute of India) with Synapse

Overview

Basic Info

Drug Type

Combination vaccine, Prophylactic vaccine

Synonyms

Quadrovax, Quadrovax PFS, Quadrovax SD

Target-

Mechanism

Immunogenetic stimulants

Therapeutic Areas

Infectious DiseasesRespiratory DiseasesOther Diseases

Active Indication

TetanusHaemophilus InfectionsDiphtheria+ [1]

Inactive Indication-

Originator Organization

Serum Institute of India Pvt Ltd.

Active Organization

Serum Institute of India Pvt Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

IN (08 Dec 2007),

Whooping Cough

Regulation-

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The DTacP-sIPV-Hib combination vaccine can replace the single-component acellular pertussis, diphtheria, tetanus, polio, and Haemophilus influenzae type B vaccines. In this study, we evaluated the safety and immunogenicity of a newly developed DTacP-sIPV-Hib combination vaccine in animal models. We used 40 mice and 46 cynomolgus monkeys to evaluate acute and long-term toxicity. Thirty-six guinea pigs were used for sensitization assessment. For immunogenicity assessment, 50 NIH mice and 50 rats were equally randomized to receive 3 doses of 3 different batches of the tested vaccine at an interval of 21 d, or physiological saline solution (0.5 mL). Orbital blood was collected at an interval of 21 d post inoculation to detect related antibody titers or neutralizing antibody titers against poliovirus. Gross autopsy and histopathological examination revealed no abnormal toxicity or irritation in mice and cynomolgus monkeys. Sensitization assessment in guinea pigs indicated the lack of evident allergic symptoms in the high- and low-dose vaccine groups within 30 min after repeated stimulation. The DTacP-sIPV-Hib combination vaccine induced significant immune responses in mice, rats, and cynomolgus monkeys, with 100% seroconversion rates after 3 doses. The DTacP-sIPV-Hib combination vaccine is safe and immunogenic in animal models. Three doses of the vaccine elicited satisfactory antibody responses in mice, rats, and cynomolgus monkeys.

02 Sep 2017·Human Vaccines & ImmunotherapeuticsQ3 · MEDICINE

A randomized, open-label clinical trial to evaluate immunogenicity and safety of an indigenously developed DTwP-Hib tetravalent combination vaccine (Easyfour®-TT) with Quadrovax® in Indian infants

Q3 · MEDICINE

Article

Author: Sharma, Sunil ; Panwar, Sachin ; Chilkoti, Deepak Chandra ; Behera, Beauty ; Paliwal, Charu ; Gupta, Anu ; Mohanty, Lalitendu ; Singh, Anit

An open-label, randomized, multi-center trial was conducted to compare the immunogenicity and safety of an indigenously developed tetravalent DTwP-Hib vaccine, Easyfour®-TT with a commercially available vaccine, Quadrovax®. A total of 244 infants in good health, aged 6-10 weeks, were randomized in a 1:1 allocation to receive three doses of the test or comparator vaccine. Immunogenicity of the vaccines was determined by measuring the baseline and post-vaccination antibody response against the vaccine antigens; safety was evaluated in terms of local and systemic reactions (solicited and unsolicited) reported during the trial. Similar levels of seroprotection/seroresponse were achieved, 4 weeks after receiving 3 doses of Easyfour®-TT and Quadrovax®, and the antibody response of Easyfour®-TT was found non-inferior to Quadrovax®, against all four vaccine antigens. Both vaccines were well tolerated and had similar reactogenicity profiles, with a significantly lower occurrence of local (redness at injection site) and systemic reactions (irritability post-vaccination) with Easyfour®-TT vaccine as compared to Quadrovax® (p < 0.05). All adverse events resolved completely with no sequelae. All through the study, only one serious adverse event was observed that completely resolved upon treatment and was deemed unrelated to the vaccine administered. This study demonstrated that Easyfour®-TT vaccine was safe and immunogenic.CLINICAL TRIAL REGISTRATION NUMBERCTRI/2014/12/005326 (registered with the Clinical Trial Registry of India (CTRI)).

01 Sep 2015·Archives de PédiatrieQ4 · MEDICINE

Réaction locale étendue à un vaccin pentavalent

Q4 · MEDICINE

Article

Author: Gébus, M ; Plantaz, D ; Bost-Bru, C ; Michard-Lenoir, A P ; Barbier, C

Injection site reactions (ISRs) are quite common side effects defined by a local adverse drug reaction directly caused by a vaccine. Twenty-four hours after an intramuscular injection (in the deltoid muscle) of the diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis, Haemophilus influenza type b (DTPCa-Hib) combined vaccine, a 3-year-old boy developed fever. A few hours later, local redness and swelling appeared at the injection site, with rapid extension to the entire limb, it was pain-free, and no other clinical anomalies were present. The patient received intravenous antibiotics for suspected cellulitis. The progression was favorable in 12h (apyrexia and decreased limb swelling), allowing the intravenous antibiotic treatment to be discontinued. Since the child was in excellent general health and recovery was fast, an ISR was diagnosed. Extensive limb swelling is frequent, mostly after the fourth dose of DTPCa-Hib. Deltoid muscle injection of DTP vaccine increases the risk of ISR compared to injection in the thigh, before the age of 3 years. The introduction of acellular pertussis vaccine decreased the risk of general side effects but may increase the risk of ISR. These reactions disappear with symptomatic treatment and do not contraindicate the product.

100 Deals associated with DTwP-Hib vaccine (Serum Institute of India)

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R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Tetanus	IN	Serum Institute of India Pvt Ltd.	24 Jan 2008
Haemophilus Infections	IN	Serum Institute of India Pvt Ltd.	22 Jan 2008
Diphtheria	IN	Serum Institute of India Pvt Ltd.	12 Dec 2007
Whooping Cough	IN	Serum Institute of India Pvt Ltd.	08 Dec 2007