Long-Term Antibody Persistence at 1, 3 and 5 Years After a Fourth Dose of GSK Biologicals' Hib-MenCY-TT Vaccine Compared to ActHIB

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Haemophilus Influenzae Type b; Neisseria Meningitidis

Treatments: Biological: Hib conjugate vaccine (ActHIB); Biological: MenHibrix (Hib-MenCY-TT)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00359983

107824

107826 (Other Identifier)

107829 (Other Identifier)

Details and patient eligibility

About

This study is evaluating antibody persistence at 1, 3 & 5 years post-fourth dose (i.e., at 2, 4 & 6 years of age, respectively) in subjects vaccinated in a previous study.

This protocol posting deals with objectives & outcome measures of the extension phase at years 1, 3 and 5. The objectives & outcome measures of the first four doses are presented in a separate protocol posting (NCT00129129).

This protocol posting has been amended in order to comply with the FDA Amendment Act of September 26, 2007.

Full description

In this long-term follow-up study, no new subjects will be recruited. All subjects participating in this long-term follow-up study should have already participated in a previous study. No vaccine will be administered during the persistence phase of the study.

This Protocol Posting has been updated following Protocol amendment 3, September 2009.

Enrollment: 270 patients

Sex: All

Ages: 22 to 60 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male and female children who completed the previous four dose vaccination series study (NCT00129129). The age of the child at the 3 post-fourth dose timelines are as follows:

  • Year 1: 22 to 36 months of age.
  • Year 3: 44 to 60 months of age.
  • Year 5: 5 years post-dose 4 +/- 8 weeks

• Written informed consent obtained from the parent or guardian of the subject.

• Healthy subjects as established by medical history and clinical examination before entering into the study

• Having completed the fourth dose vaccination of study Hib-MenCY-TT-005/006

Exclusion criteria

Children should not have:

• received more than 4 doses of Hib or meningococcal serogroup C and Y vaccine
• had a history of H. influenzae type b, meningococcal serogroup C and Y diseases

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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270 participants in 3 patient groups

MenHibrix 4-dose group

Experimental group

Description:

Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.

Treatment:

Biological: MenHibrix (Hib-MenCY-TT)

ActHIB 4-dose group

Active Comparator group

Description:

Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.

Treatment:

Biological: Hib conjugate vaccine (ActHIB)

ActHIB 3-dose + MenHibrix 4th-dose group

Experimental group

Description:

Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.

Treatment:

Biological: MenHibrix (Hib-MenCY-TT)

Biological: Hib conjugate vaccine (ActHIB)