Study to Evaluate GSK Biologicals' GSK2197870A Vaccine Given as Primary Course in Infants

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Haemophilus Influenzae Type b; Neisseria Meningitidis

Treatments: Biological: Pediacel™; Biological: GSK2197870A; Biological: Prevenar™; Biological: Menitorix™; Biological: Menjugate™

Study type: Interventional

Funder types: Industry

Identifiers

NCT00871338

111709

Details and patient eligibility

About

The purpose of this Phase II study is to evaluate the feasibility of GSK Biologicals' GSK2197870A vaccine co-administered with Wyeth-Lederle's Prevenar™ when given in healthy infants as a three-dose primary vaccination course at 2, 3 and 4 months of age followed by a booster dose of GSK Biologicals' Menitorix™ at 12 months of age.

Full description

This protocol posting has been updated following Protocol amendment 1, 11-February-2010; The Study design section is impacted by this amendment.

Enrollment: 284 patients

Sex: All

Ages: 6 to 12 weeks old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

All subjects must satisfy the following criteria at study entry:

• A male or female infant between, and including, 6 and 12 weeks of age at the time of the first vaccination.
• Born after 36 to 42 weeks of gestation.
• Subjects who the investigator believes that their parents/ guardians can and will comply with the requirements of the protocol should be enrolled in the study.
• 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.

Exclusion criteria

The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study:

• Use of any investigational or non-registered product 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 of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone, or equivalent, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed.
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
• Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period.
• Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product .
• Evidence of previous or intercurrent diphtheria, tetanus, pertussis, poliomyelitis, Hib, pneumococcal and/or group C meningococcal vaccination or disease.
• History of seizures or progressive neurological disease (one episode of febrile convulsion does not constitute an exclusion criterion).
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
• Major congenital defects or serious chronic illness.

The following condition is temporary or self limiting and a subject may be vaccinated once the condition has resolved and no other exclusion criteria are met:

• Current febrile illness or axillary temperature ≥37.5ºC or other moderate to severe illness within 24 hours of study vaccine administration

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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284 participants in 2 patient groups

GSK2197870A Group

Experimental group

Description:

Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.

Treatment:

Biological: Menitorix™

Biological: Prevenar™

Biological: GSK2197870A

Pediacel Group

Active Comparator group

Description:

Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.

Treatment:

Biological: Menjugate™

Biological: Menitorix™

Biological: Prevenar™

Biological: Pediacel™