Assess Feasibility of an Acellular Pertussis Vaccine (Pa) Given Soon After Birth, Followed by 3-dose Primary Vaccination With the DTPa-HBV-IPV/Hib Vaccine

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Hepatitis B

Treatments: Biological: DTPa-HBV-IPV/Hib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00289796

210602-002

105752 (Other Identifier)

Details and patient eligibility

About

This study will assess immunogenicity, safety and reactogenicity of primary and booster vaccination.

Full description

"There will be two groups in this study:

• one group will receive a birth dose of Pa vaccine and 3 doses of DTPa-HBV-IPV/Hib vaccine as primary vaccination and a dose of DTPa-HBV-IPV/Hib vaccine as booster vaccination
• the control group will receive a birth dose of hepatitis B vaccine and 3 doses of DTPa-HBV-IPV/Hib vaccine as primary vaccination and a dose of DTPa-HBV-IPV/Hib vaccine as booster vaccination".

Enrollment: 121 patients

Sex: All

Ages: 2 to 5 days old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria For the primary vaccination phase

• Healthy newborn male or female infant 2 to 5 days old at the time of the first vaccination & written informed consent taken from the parents/guardians of the subject
• Born at term (gestational age 37-42 weeks) after an uncomplicated pregnancy
• Birth weight >= 2.5 kg and 5 minute Apgar >= 7
• Mother seronegative for Hepatitis B surface antigen (HBsAg) For the booster vaccination phase
• A healthy male or female between, and including, 12 and 23 months of age at the time of booster vaccination who has completed the primary vaccination course in the primary vaccination phase with written informed consent obtained from the parent or guardian of the subject

Exclusion criteria For the primary vaccination phase

• Mother known or suspected to be seropositive for HIV (testing not required for inclusion)
• Planned use of any investigational or non-registered product (drug or vaccine) other than the study vaccines during the study
• Planned administration of immuno-suppressants or other immune-modifying drugs, administration of immunoglobulins and/or any blood products since birth or planned administration during the study.
• Administration of immunoglobulins and/or any blood products to the mother during pregnancy
• Neonatal jaundice requiring parenteral treatment (light therapy for physiological jaundice is allowed)
• At risk of pneumococcal disease or planning to receive Prevenar™ during the study period
• Administration or planned administration of BCG vaccination during the study period
• Acute disease at the time of vaccination. For the booster vaccination phase
• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the booster dose, or planned use during the booster phase.
• Evidence of previous diphtheria, tetanus, pertussis, polio, hepatitis B and/or Hib booster vaccination since the study conclusion visit of the primary vaccination phase.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
• Administration/ planned administration of a vaccine not foreseen by the study protocol, administration/ planned administration of immunoglobulins and/or any blood products during the period starting 30 days before the administration of the booster dose and ending 30 days after the booster dose.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccine dose."

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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121 participants in 1 patient group

Infanrix hexa Group

Active Comparator group

Description:

Subjects received a dose of hepatitis B vaccine at birth followed by immunization with 3 doses of Infanrix hexa™ (2, 4 and 6 months of age) and one booster dose of Infanrix hexa™ between 12 and 23 months of age. All vaccines were administered by deep intramuscular injection into the left anterolateral thigh.

Treatment:

Biological: DTPa-HBV-IPV/Hib