Immunogenicity and Safety Study of GSK Biologicals' GSK2202083A Vaccine in Healthy Infants at 2, 3 and 4 Months of Age

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Poliomyelitis; Haemophilus Influenzae Type b; Diphtheria; Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b-Neisseria Meni; Hepatitis B; Tetanus; Acellular Pertussis

Treatments: Biological: Infanrix hexa™; Biological: Menjugate®; Biological: GSK2202083A vaccine; Biological: 10-valent pneumococcal vaccine (GSK 1024850A)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00970307

112157

2009-010431-41 (EudraCT Number)

Details and patient eligibility

About

This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083A vaccine co-administered with GSK Biologicals' 10-valent pneumococcal conjugate (GSK1024850A) vaccine given as a three-dose primary vaccination course at 2, 3 and 4 months of age.

Full description

In accordance with the local recommended immunisation schedule, all subjects will receive 2 doses of GSK Biologicals' Human Rotavirus Vaccine (Rotarix) at 2 and 3 months of age.

Enrollment: 421 patients

Sex: All

Ages: 8 to 12 weeks old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• A male or female infant between, and including, 8 and 12 weeks of age at the time of the first vaccination.
• Born after a gestation period of 36 to 42 weeks inclusive.
• Subjects should have received one dose of hepatitis B vaccination at birth as per local recommendations.
• Subjects who the investigator believes that their parent(s)/LAR can and will comply with the requirements of the protocol.
• Written informed consent obtained from the parent/LAR of the subject.
• Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion criteria

• Use of any investigational or non-registered product other than the study vaccines 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.
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
• Administration of any vaccine since birth, with exception of HBV and Bacillus Calmette-Guérin, 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, hepatitis B, polio, Hib, pneumococcal and/or MenC disease.
• History of seizures or progressive neurological disease.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
• 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 if no other exclusion criteria is met:

• Current febrile illness or axillary temperature >= 38.5 ºC 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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421 participants in 3 patient groups

GSK2202083A + SYNFLORIX GROUP

Experimental group

Description:

Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.

Treatment:

Biological: 10-valent pneumococcal vaccine (GSK 1024850A)

Biological: GSK2202083A vaccine

INFANRIX HEXA + MENJUGATE GROUP

Active Comparator group

Description:

Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.

Treatment:

Biological: Menjugate®

Biological: Infanrix hexa™

INFANRIX HEXA + SYNFLORIX GROUP

Active Comparator group

Description:

Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.

Treatment:

Biological: 10-valent pneumococcal vaccine (GSK 1024850A)

Biological: Infanrix hexa™