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

NCT00970307 | Completed Phase 2 Results

• 2 other identifiers: 1121572009-010431-41
• Study Type: interventional
• Target: 421
• Locations: 1 country
• Sites: 9

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Number of Seroprotected Subjects Against Polyribosyl-Ribitol-Phosphate (PRP)

  A seroprotected subject was defined as a subject with anti-PRP antibody concentrations greater than or equal to (≥) 0.15 micrograms per milliliter (µg/mL).

  At Month 3

• Number of Seroprotected Subjects Against Neisseria Meningitidis Serogroup C Using Baby Rabbit Complement (rSBA-MenC)

  A seroprotected subject was defined as a subject with rSBA-MenC titers greater than or equal to (≥) 1:8.

  At Month 3

Secondary Outcomes (21)

• Anti-PRP Antibody Concentrations

  At Months 0 and 3

• Antibody Titers Against rSBA-MenC

  At Months 0 and 3

• Number of Seropositive Subjects for Anti-polysaccharide Neisseria Meningitidis Serogroup C (Anti-PSC)

  At Month 3

• Anti-PSC Antibody Concentrations

  At Months 0 and 3

• Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T)

  At Month 3

Study Arms (3)

GSK2202083A + SYNFLORIX GROUP

EXPERIMENTAL

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.

Biological: GSK2202083A vaccine; Biological: 10-valent pneumococcal vaccine (GSK 1024850A)

INFANRIX HEXA + MENJUGATE GROUP

ACTIVE COMPARATOR

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.

Biological: Infanrix hexa™; Biological: Menjugate®

INFANRIX HEXA + SYNFLORIX GROUP

ACTIVE COMPARATOR

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.

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

Interventions

GSK2202083A vaccine BIOLOGICAL

Intramuscular, three doses

GSK2202083A + SYNFLORIX GROUP

10-valent pneumococcal vaccine (GSK 1024850A) BIOLOGICAL

Intramuscular, three doses

GSK2202083A + SYNFLORIX GROUP; INFANRIX HEXA + SYNFLORIX GROUP

Infanrix hexa™ BIOLOGICAL

Intramuscular, three doses

INFANRIX HEXA + MENJUGATE GROUP; INFANRIX HEXA + SYNFLORIX GROUP

Menjugate® BIOLOGICAL

Intramuscular, two doses

INFANRIX HEXA + MENJUGATE GROUP

Eligibility Criteria

• Age: 8 Weeks - 12 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (9)

GSK Investigational Site

Bydgoszcz, 85-021, Poland

Location

GSK Investigational Site

Dębica, 39-200, Poland

Location

GSK Investigational Site

Krakow, 31-503, Poland

Location

GSK Investigational Site

Krakow, Poland

Location

GSK Investigational Site

Siemianowice Śląskie, 41-103, Poland

Location

GSK Investigational Site

Tarnów, 33-100, Poland

Location

GSK Investigational Site

Torun, Poland

Location

GSK Investigational Site

Trzebnica, 55-100, Poland

Location

GSK Investigational Site

Wroclaw, 50345, Poland

Location

Related Publications (1)

• 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.

  PMID: 23838777 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Tetanus; Diphtheria; Haemophilus Infections; Poliomyelitis; Hepatitis B

Interventions

10-valent pneumococcal vaccine; diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine

Condition Hierarchy (Ancestors)

Clostridium Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Corynebacterium Infections; Actinomycetales Infections; Pasteurellaceae Infections; Gram-Negative Bacterial Infections; Myelitis; Central Nervous System Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases; Blood-Borne Infections; Communicable Diseases; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2009
• First Posted: September 2, 2009
• Study Start: August 13, 2009
• Primary Completion: January 27, 2010
• Study Completion: January 27, 2010
• Last Updated: January 3, 2020
• Results First Posted: April 14, 2017

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

PL (9)