Comparison of a DTaP-IPV-HB-PRP~T Combined Vaccine to Infanrix™-Hexa, When Administered With Prevnar® in Thai Infants

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

412 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2008-08-31

Brief Summary

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The purpose of the study is to provide immunogenicity and safety data of the investigational hexavalent vaccine when it is given concomitantly (the same day at separate injection sites) with Prevnar, according to the 2-4-6 month immunization schedule, following one dose of HB vaccine at birth.

Primary Objective:

To demonstrate that the hexavalent DTaP-IPV-HB-PRP\~T combined vaccine induces an immune response that is at least as good as the response following Infanrix™-Hexa in terms of seroprotection rates to HB and PRP, one month after a 3 dose primary series (2, 4, and 6 months), when co-administered with Prevnar®

Secondary Objectives:

Immunogenicity:

To describe in each group the immunogenicity parameters to each vaccine component (for DTaP-IPV-HB-PRP\~T and Infanrix™-Hexa) one month after the third dose of the primary series.

Safety:

To describe the overall safety after each injection.

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Detailed Description

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Conditions

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Hepatitis B Polio Diphtheria Pertussis Haemophilus Influenzae Type b

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Group 1: DTaP IPV Hep B PRP T + Prevnar™

Group Type EXPERIMENTAL

DTaP-IPV-HB-PRP~T and Pneumococcal polysaccharide vaccines

Intervention Type BIOLOGICAL

0.5 mL, IM

Group 2: Infanrix hexa™ + Prevnar™

Group Type ACTIVE_COMPARATOR

DTaP-HB-IPV and Pneumococcal polysaccharide vaccines

Intervention Type BIOLOGICAL

0.5 mL, IM

Interventions

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DTaP-IPV-HB-PRP~T and Pneumococcal polysaccharide vaccines

0.5 mL, IM

Intervention Type BIOLOGICAL

DTaP-HB-IPV and Pneumococcal polysaccharide vaccines

0.5 mL, IM

Intervention Type BIOLOGICAL

Other Intervention Names

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Prevnar® Infanrix™-Hexa Prevnar®

Eligibility Criteria

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Inclusion Criteria

* Two month old infant (50 to 71 days old) on the day of inclusion, of either gender.
* Born at full term of pregnancy (\>= 37 weeks) and with a birth weight \>= 2.5 kg.
* Hepatitis B vaccination since birth.
* Informed consent form signed by one parent/legally acceptable representative and an independent witness if the parent/legally acceptable representative is illiterate.
* Able to attend all scheduled visits and to comply with all trial procedures.

Exclusion Criteria

* Participation in another clinical trial in the 4 weeks preceding the first trial vaccination.
* Planned participation in another clinical trial during the present trial period.
* Systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to the trial vaccine or a vaccine containing the same substances.
* Congenital or acquired immunodeficiency, or immunosuppressive therapy such as long-term systemic corticosteroid therapy.
* Chronic illness at a stage that could interfere with trial conduct or completion.
* Blood or blood-derived products received since birth.
* Any vaccination in the 4 weeks preceding the first trial vaccination.
* Any planned vaccination (except trial vaccinations) during the trial.
* Documented history of pertussis, T, D, polio, Hib, hepatitis B or Streptococcus pneumoniae infection(s) (confirmed either clinically, serologically, or microbiologically).
* Previous vaccination against pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b infection(s) or Streptococcus pneumoniae.
* Known personal or maternal history of HIV, HB (HbsAg carrier) or hepatitis C seropositivity.
* Known thrombocytopenia or bleeding disorder contraindicating IM vaccination.
* History of seizures.
* Febrile (rectal equivalent temperature \>= 38.0°C) or acute illness on the day of inclusion.

Minimum Eligible Age

50 Days

Maximum Eligible Age

71 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes