Safety Study of a Vaccine Against Meningitis in Infants (2,4 & 6 Months Age) After a Birth Dose of Hepatitis B.

NCT00317187 | Completed Phase 3

• 1 other identifier: 100791
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the reactogenicity \& safety of Tritanrix™-HepB/Hib-MenAC vaccine to the international standard of care, Tritanrix™-HepB/Hiberix™.

Conditions

Hepatitis B; Diphtheria; Whole Cell Pertussis; Tetanus; Haemophilus Influenzae Type b

Outcome Measures

Primary Outcomes (3)

• Occurrence of fever > 38.5°C(axillary) during the 4-day follow-up period after dose 1

  Days 0-3 post dose 1

• Occurrence of fever > 38.5°C(axillary) during the 4-day follow-up period after dose 2

  Days 0-3 post dose 2

• Occurrence of fever > 38.5°C(axillary) during the 4-day follow-up period after dose 3

  Days 0-3 post dose 3

Secondary Outcomes (3)

• Occurrence of solicited symptoms other than fever >38.5°C (axillary) during the 4-day follow-up period after each dose

  Days 0-3 after each dose

• Occurrence of unsolicited symptoms during the 31-day follow-up period after each dose

  Day 0-30 after each dose

• Occurrence of serious adverse events during the entire study period

  Day 0 up to Month 5

Study Arms (4)

Hib-MenAC Lot 1 Group

EXPERIMENTAL

Healthy male or female subjects aged 56 to 83 days of age at the time of the first study vaccine dose, with previous hepatitis B vaccine at birth, received Tritanrix-HepB combined vaccine mixed extemporaneously with Meningitec conjugate vaccine Lot 1 at 2, 4 and 6 months of age as an intramuscular injections in the anterolateral part of the left thigh.

Biological: Tritanrix-HepB/Meningitec conjugate vaccine

Hib-MenAC Lot 2 Group

EXPERIMENTAL

Healthy male or female subjects aged 56 to 83 days of age at the time of the first study vaccine dose, with previous hepatitis B vaccine at birth, received Tritanrix-HepB combined vaccine mixed extemporaneously with Meningitec conjugate vaccine Lot 2 at 2, 4 and 6 months of age as an intramuscular injections in the anterolateral part of the left thigh.

Biological: Tritanrix-HepB/Meningitec conjugate vaccine

Hib-MenAC Lot 3 Group

EXPERIMENTAL

Healthy male or female subjects aged 56 to 83 days of age at the time of the first study vaccine dose, with previous hepatitis B vaccine at birth, received Tritanrix-HepB combined vaccine mixed extemporaneously with Meningitec conjugate vaccine Lot 3 at 2, 4 and 6 months of age as an intramuscular injections in the anterolateral part of the left thigh.

Biological: Tritanrix-HepB/Meningitec conjugate vaccine

Hiberix Group

ACTIVE COMPARATOR

Healthy male or female subjects aged 56 to 83 days of age at the time of the first study vaccine dose, with previous hepatitis B vaccine at birth, received Tritanrix-HepB vaccine mixed extemporaneously with conjugate vaccine Hiberix at 2, 4 and 6 months of age as intramuscular injection in the anterolateral part of the thigh.

Biological: Tritanrix/Hiberix vaccine

Interventions

Tritanrix-HepB/Meningitec conjugate vaccine BIOLOGICAL

The full content of two monodose vials of Tritanrix-HepB vaccine vial was extracted and injected into the vial containing the lyophilized Meningitec (5/5/5) vaccine. The vial was agitated until the lyophilized vaccine pellet had completely dissolved. The reconstituted mixed vaccines were used promptly after reconstitution (within 30 minutes): one dose of 0.5 ml of the reconstituted Tritanrix- HepB/Meningitec vaccine was withdrawn from the vial and administered, the needle was changed before injection

Also known as: DTPw-HBV/Hib-MenAC conjugate vaccine

Hib-MenAC Lot 1 Group; Hib-MenAC Lot 2 Group; Hib-MenAC Lot 3 Group

Tritanrix/Hiberix vaccine BIOLOGICAL

The full content of the Tritanrix-HepB vaccine vial was extracted and injected into the vial containing the lyophilized Hiberix vaccine. The vial was agitated until the lyophilized vaccine pellet had completely dissolved. The reconstituted mixed vaccines were used promptly after reconstitution (within 30 minutes): the full volume of the mixed vaccines was withdrawn from the vial, the needle was changed before injection.

Also known as: DTPw-HBV/Hib vaccine

Hiberix Group

Eligibility Criteria

• Age: 56 Days - 83 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy infants 56-83 days of age at the time of the first vaccine dose, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks \& has received a birth dose of hepatitis B vaccine within the first 3 days of life.

You may not qualify if:

• Any confirmed immunodeficient condition, based on medical history and physical examination.
• Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before the first dose of study vaccine, or planned administration during the study period with the exception of oral polio vaccine (OPV).
• Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
• Bacille Calmette-Guérin (BCG) vaccine received after the first 2 weeks of life.
• Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae type b, and/or meningococcal disease.
• History of diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and/or meningococcal disease or known exposure to these diseases since birth.
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Bangkok, 10400, Thailand

Location

Related Publications (1)

• Kerdpanich A, Warachit B, Kosuwon P, Gatchalian SR, Watanaveeradej V, Borkird T, Kosalaraksa P, Han HH, Hutagalung Y, Boutriau D, Dobbelaere K. Primary vaccination with a new heptavalent DTPw-HBV/Hib-Neisseria meningitidis serogroups A and C combined vaccine is well tolerated. Int J Infect Dis. 2008 Jan;12(1):88-97. doi: 10.1016/j.ijid.2007.06.002. Epub 2007 Aug 22.

  PMID: 17716936 DERIVED

MeSH Terms

Conditions

Hepatitis B; Diphtheria; Tetanus; Haemophilus Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Clostridium Infections; Pasteurellaceae Infections; Gram-Negative Bacterial Infections

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2006
• First Posted: April 24, 2006
• Study Start: June 8, 2004
• Primary Completion: January 16, 2005
• Study Completion: January 16, 2005
• Last Updated: August 15, 2018

Record last verified: 2018-08

Locations

TH (1)