Delving into the Latest Updates on Hib-DTP vaccine (sanofi pasteur) with Synapse

Overview

Basic Info

Drug Type

Combination vaccine, Prophylactic vaccine

Synonyms

ActHIB DTP, ProHIBITDPT, TETRActHIB

Target-

Action

stimulants

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesRespiratory DiseasesOther Diseases

Active Indication

Whooping CoughTetanusDiphtheria

Inactive Indication-

Originator Organization

Sanofi Pasteur SA

Active Organization-

Inactive Organization-

License Organization-

Drug Highest PhaseApproved

First Approval Date

South Africa (25 Jan 1998),

Diphtheria

Regulation-

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GSK Biologicals in partnership with the Malaria Vaccine Initiative at PATH is developing a candidate malaria vaccine GSK 257049 for the routine immunization of infants and children living in malaria endemic areas. The vaccine would offer protection against malaria disease due to the parasite Plasmodium falciparum. The vaccine would also provide protection against infection with hepatitis B virus (HBV).
In order to integrate the malaria vaccine into the EPI regimen in malaria-endemic regions, a new variant RTS,S/AS02D (0.5 mL dose) has been developed.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Start Date27 Sep 2006

Sponsor / Collaborator

GSK Plc

NCT00197028

/ CompletedPhase 2

A Phase I/IIb Randomized, Double-blind, Controlled Study of the Safety, Immunogenicity and Proof-of-concept of RTS,S/AS02D, a Candidate Malaria Vaccine in Infants Living in a Malaria-endemic Region

GSK Biologicals is developing in partnership with the Program for Appropriate Technology in Health (PATH) Malaria Vaccine Initiative a candidate malaria vaccine for the routine immunization of infants and children living in malaria endemic areas. The vaccine would offer protection against malaria disease due to the parasite Plasmodium falciparum. The vaccine would also provide protection against infection with hepatitis B virus (HBV).
This trial is being carried out following the demonstration of efficacy of a previous version of the malaria candidate vaccine in children in Mozambique: there, the vaccine demonstrated approximately 30% efficacy against clinical episodes of malaria and approximately 58% efficacy against severe malaria disease.
In order to integrate the malaria vaccine into the Expanded Program on Immunization (EPI) regimen, in malaria-endemic regions, for this trial, a 0.5 ml dose of GSK 257049 vaccine has been developed. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Start Date23 Aug 2005

Sponsor / Collaborator

GSK Plc

100 Clinical Results associated with Hib-DTP vaccine (sanofi pasteur)

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100 Translational Medicine associated with Hib-DTP vaccine (sanofi pasteur)

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100 Patents (Medical) associated with Hib-DTP vaccine (sanofi pasteur)

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5

Literatures (Medical) associated with Hib-DTP vaccine (sanofi pasteur)

01 Nov 2011·VaccineQ3 · MEDICINE

A phase III randomized, controlled study to assess and compare the immunogenicity and tolerability of single and multi-dose vials of DTwP-Hib, a fully liquid quadravalent vaccine and their comparison with TETRAct-Hib vaccine in Indian infants aged 6–14 weeks

Q3 · MEDICINE

Article

Author: Sangita Yadav ; Sunil Bahl ; Arun Prasath ; Hitt Sharma ; Suresh Jadhav ; Vishwanath Patil ; Satish Ravetkar ; Girija Ashtagi ; Sameer Parekh ; Subhash Kapre ; Anita Chakravarty ; Betty Chacko

Both WHO and IAP encourage using combination vaccines, wherever feasible. The phase III trial reported here was conducted to assess and compare the immunogenicity, tolerability and safety of two quadravalent vaccines, Quadrovax(®) (new vaccine), and TETRAct-Hib(®) (available in the market) in a multicentre study, in India. In all, 361 infants aged 6-8 weeks were enrolled, out of which 339 completed the study. The vaccination was done at 6-10-14 weeks following EPI/WHO recommended immunization schedule. Blood samples were collected prior to the administration of first dose and one month after the third dose. Postvaccination, geometric mean titres for each component did not differ significantly between the single dose vial and multi dose vial subgroups and among the two study groups. Adverse events observed were within the range quoted in literature. Quadrovax(®) vaccine manufactured by SIIL was found to be safe, immunogenic and non-inferior to the comparator vaccine. The quadravalent vaccine is best recommended in the second year of life when children receive their booster dose at 15-18 months. It can be given to infants during primary immunization series at 6, 10 and 14 weeks of age when Hepatitis B vaccine is given in a separate arm or to infants at 10 weeks who receive the Hepatitis B vaccine separately following the 0, 6 and 14 weeks or 0, 1 and 6 months schedule.

01 Sep 2004·Archives of Disease in Childhood - Fetal and Neonatal Edition

DTP immunisation of steroid treated preterm infants

Letter

Author: M J Robinson ; P J Powell ; P Clarke

Preterm infants respond well to the three doses of diphtheria, tetanus, and whole cell pertussis (DTP) vaccine,1 but dexamethasone treatment may impair immunogenicity.2,3 We investigated whether four, rather than three, DTP doses may be preferable for primary immunisation of steroid treated preterm infants. Twelve infants born at < 30 weeks gestation who had received dexamethasone for chronic lung disease were given doses of DTP vaccine combined with Hib (ActHIB DTP; Pasteur-Merieux-MSD) at 2, 3, and 4 months of age. A fourth dose was administered six weeks after the third immunisation (table 1). With the use …

01 May 2002·Indian pediatricsQ4 · MEDICINE

Safety and immunogenicity of Haemophilus influenzae type B vaccine given in combination with DTwP at 6, 10 and 14 weeks of age.

Q4 · MEDICINE

Article

Author: Cherian, Thomas ; Thomas, Niranjan ; Dutta, Anil ; Raghupathy, P ; Durot, Isabelle

OBJECTIVETo assess the immunogenicity and reactogenicity of a tetanus conjugate Haemophilus influenzae type b vaccine (Act-Hib) when extemporaneously mixed and administered as a DTwP-Hib combination using an Indian DTwP vaccine (BE DTwP) in comparison with a licensed DTwP-Hib combination vaccine.METHODS378 healthy infants were enrolled and randomly allocated to receive either three doses, at 6, 10 and 14 weeks of age, of Act-Hib in combination with BE DTwP (Group A, n = 160), TetrAct-Hib (Group B, n = 160), or BE DTwP and Act-Hib as separate injections (Group C, n = 58). Sera collected before the first dose and one month after the third dose were tested for antibodies to vaccine antigens. Safety was determined using parental diary cards.RESULTSAnti-Hib antibody concentrations indicative of short-term protection (> 0.15 g/ml) were elicited in all but one subject in Group A (99.3%), and all subjects in Groups B and C. The concentration of 1 g/ml, considered to provide long-term protection, was achieved in 96.7%, 100% and 98.2% of the infants in Groups A, B and C, respectively. All children displayed satisfactory responses to the three DTwP component antigens, TetrAct-Hib eliciting higher titers against diphtheria and tetanus than BE DTwP. No vaccine-associated serious adverse events occurred. The BE DTwP vaccine was associated with more reports of fever than TetrAct-Hib, but most symptoms were regarded as mild and all resolved without sequelae.CONCLUSIONSCombining Act-Hib and a local DTwP vaccine did not affect the anti-Hib response. In countries where DTwP vaccine available for use in the EPI program is manufactured by a local or other developing country manufacturer, mixing it with lyophilised Act-Hib is a reasonable option though the immunogenicity may have to be documented before routine use. However, use of TetrAct-Hib combination vaccine would be preferable in view of its lower reactogenicity and superior immunogenicity with respect to diphtheria and tetanus.

100 Deals associated with Hib-DTP vaccine (sanofi pasteur)

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R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Whooping Cough	South Africa	-	05 Feb 1998
Tetanus	South Africa	-	01 Feb 1998
Diphtheria	South Africa	-	25 Jan 1998

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00289185 (CTgov)	Phase 2	Malaria	340	TETRActHib™+Engerix-B® (Engerix-B Group)	mrnyivnydx(aefjlpdfkw) = alhbsgdxrd qdgnqfsgdt (wofgnufbzu, xwutdyzsum - zpersskxly) View more	-	08 Jul 2013
				TETRActHib™+RTS,S/AS02D (RTS,S/AS02D Group)	mrnyivnydx(aefjlpdfkw) = jvqclukkyc qdgnqfsgdt (wofgnufbzu, rnzhkyfjgr - nulgglkzpy) View more
NCT00197028 (not provided, CTgov)	Phase 2	Malaria	214	TETRActHib™+RTS,S/AS02D (RTS,S/AS02D Group)	ynwzhlbukw(cwsdgsdazp) = syjywpdyfr muapdtxuek (ggpoecwade, eppwpgkrta - psqmllicgu) View more	-	18 Jan 2013
				TETRActHib™+Engerix-B® (Engerix-B Group)	ynwzhlbukw(cwsdgsdazp) = nybvfkedxt muapdtxuek (ggpoecwade, czuijxfkmi - erpumzutpv) View more