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

GlaxoSmithKline (GSK) logo

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)

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™

Trial contacts and locations

9

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Data sourced from clinicaltrials.gov

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