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

NCT ID: NCT00970307

Last Updated: 2020-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 421 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-13
• Study Completion Date: 2010-01-27

Brief Summary

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.

Detailed 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

GSK2202083A + SYNFLORIX GROUP

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.

Group Type: EXPERIMENTAL

GSK2202083A vaccine

Intervention Type: BIOLOGICAL

Intramuscular, three doses

10-valent pneumococcal vaccine (GSK 1024850A)

Intervention Type: BIOLOGICAL

Intramuscular, three doses

INFANRIX HEXA + MENJUGATE GROUP

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.

Group Type: ACTIVE_COMPARATOR

Infanrix hexa™

Intervention Type: BIOLOGICAL

Intramuscular, three doses

Menjugate®

Intervention Type: BIOLOGICAL

Intramuscular, two doses

INFANRIX HEXA + SYNFLORIX GROUP

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.

Group Type: ACTIVE_COMPARATOR

10-valent pneumococcal vaccine (GSK 1024850A)

Intervention Type: BIOLOGICAL

Intramuscular, three doses

Infanrix hexa™

Intervention Type: BIOLOGICAL

Intramuscular, three doses

Interventions

GSK2202083A vaccine

Intramuscular, three doses

Intervention Type: BIOLOGICAL

10-valent pneumococcal vaccine (GSK 1024850A)

Intramuscular, three doses

Intervention Type: BIOLOGICAL

Infanrix hexa™

Intramuscular, three doses

Intervention Type: BIOLOGICAL

Menjugate®

Intramuscular, two doses

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Current febrile illness or axillary temperature >= 38.5 ºC or other moderate to severe illness within 24 hours of study vaccine administration.

• Minimum Eligible Age: 8 Weeks
• Maximum Eligible Age: 12 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Bydgoszcz, , Poland

GSK Investigational Site

Dębica, , Poland

GSK Investigational Site

Krakow, , Poland

GSK Investigational Site

Krakow, , Poland

GSK Investigational Site

Siemianowice Śląskie, , Poland

GSK Investigational Site

Tarnów, , Poland

GSK Investigational Site

Torun, , Poland

GSK Investigational Site

Trzebnica, , Poland

GSK Investigational Site

Wroclaw, , Poland

Countries

Poland

References

Szenborn L, Czajka H, Brzostek J, Konior R, Caubet M, Ulianov L, Leyssen M. A randomized, controlled trial to assess the immunogenicity and safety of a heptavalent diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, hib and meningococcal serogroup C combination vaccine administered at 2, 3, 4 and 12-18 months of age. Pediatr Infect Dis J. 2013 Jul;32(7):777-85. doi: 10.1097/INF.0b013e31828d6b20.

Reference Type: BACKGROUND

PMID: 23838777 (View on PubMed)

Study Documents

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

2009-010431-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

112157

Identifier Type: -

Identifier Source: org_study_id