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

NCT ID: NCT00317187

Last Updated: 2018-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-08
• Study Completion Date: 2005-01-16

Brief Summary

The purpose of this study is to compare the reactogenicity & safety of Tritanrixâ„¢-HepB/Hib-MenAC vaccine to the international standard of care, Tritanrixâ„¢-HepB/Hiberixâ„¢.

Detailed Description

Randomized study with four groups to receive one of the following vaccination regimens after a dose of hepatitis B vaccine given at birth:

• One of the 3 lots of GSK Biologicals' Hib-MenAC mixed with GSK Biologicals' Tritanrixâ„¢-HepB (3 different groups)
• GSK Biologicals' Tritanrixâ„¢-HepB/Hiberixâ„¢

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION

Study Groups

Hib-MenAC Lot 1 Group

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.

Group Type: EXPERIMENTAL

Tritanrix-HepB/Meningitec conjugate vaccine

Intervention Type: 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reconstitution (within 30 minutes): one dose of 0.5 ml of the reconstituted Tritanrix- HepB/Meningitec vaccine was withdrawn from the vial and administered, the needle was changed before injection

Hib-MenAC Lot 2 Group

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.

Group Type: EXPERIMENTAL

Tritanrix-HepB/Meningitec conjugate vaccine

Intervention Type: 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

Hib-MenAC Lot 3 Group

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.

Group Type: EXPERIMENTAL

Tritanrix-HepB/Meningitec conjugate vaccine

Intervention Type: 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

Hiberix Group

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.

Group Type: ACTIVE_COMPARATOR

Tritanrix/Hiberix vaccine

Intervention Type: 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.

Interventions

Tritanrix-HepB/Meningitec conjugate vaccine

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

Intervention Type: BIOLOGICAL

Tritanrix/Hiberix vaccine

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.

Intervention Type: BIOLOGICAL

Other Intervention Names

DTPw-HBV/Hib-MenAC conjugate vaccine; DTPw-HBV/Hib vaccine

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 56 Days
• Maximum Eligible Age: 83 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Bangkok, , Thailand

Countries

Thailand

References

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.

Reference Type: DERIVED

PMID: 17716936 (View on PubMed)

Other Identifiers

100791

Identifier Type: -

Identifier Source: org_study_id