Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6-12wks of Age
Non-inferiority of a Commercial Lot of the Pneumococcal Vaccine GSK1024850A Compared to a Clinical Lot.
1 other identifier
interventional
466
2 countries
5
Brief Summary
The purpose of the present study is to demonstrate that the changes in the manufacturing process for the commercial lot of the pneumococcal conjugate vaccine GSK1024850A have no clinical impact and that the immune responses are non-inferior to the immune responses induced by the clinical lot. The study will be conducted in Singapore and Malaysia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2009
Shorter than P25 for phase_3
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 11, 2008
CompletedFirst Posted
Study publicly available on registry
December 15, 2008
CompletedStudy Start
First participant enrolled
January 5, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 2, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 2, 2009
CompletedResults Posted
Study results publicly available
November 19, 2010
CompletedAugust 17, 2018
October 1, 2016
10 months
December 11, 2008
October 25, 2010
July 11, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Concentrations of Antibodies Against Vaccine Components of the Pneumococcal Vaccine
Concentrations are given as Geometric Mean Concentrations (GMCs) in microgram per milliliter (μg/mL). Vaccine pneumococcal serotypes assessed included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
One month after primary immunization (month 4)
Concentration of Antibody Against Protein D (PD)
Concentration was expressed as GMC in GSK's 22F enzyme-linked-immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
One month after primary immunization (month 4)
Secondary Outcomes (15)
Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 µg/mL
One month after primary immunization (month 4)
Number of Subjects With Anti-pneumococcal Cross-reactive Serotype Concentrations Equal to or Above 0.20 µg/mL
One month after primary immunization (month 4)
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes
One month after primary immunization (month 4)
Number of Subjects With Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes
One month after primary immunization (month 4)
Opsonophagocytic Titers of Cross-reactive Pneumococcal Serotypes
One month after primary immunization (month 4)
- +10 more secondary outcomes
Study Arms (2)
Synflorix Clinical Lot & Infanrix Group
EXPERIMENTALSubjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
Synflorix Commercial Lot Infanrix Group
EXPERIMENTALSubjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
Interventions
Intramuscular injection, 3 doses
Intramuscular injection, 3 doses in Malaysia and 2 doses in Singapore
Intramuscular injection, only for Visit 2 in Singapore
Oral, 2 doses
Eligibility Criteria
You may qualify if:
- Male or female subjects between, and including 6-12 weeks of age at the time of the first vaccination.
- Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol.
- Written or oral, signed or thumb-printed informed consent obtained from the parent(s)/guardian(s) of the child/ward.
- Free of any known or suspected health problems (as established by medical history and clinical examination before entering into the study).
- Born after a gestation period of \>= 36 to \<= 42 weeks.
You may not qualify if:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of the study vaccines, or planned use during the study period.
- Concurrently participating in another clinical study, at any time during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
- A family history of congenital or hereditary immunodeficiency.
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period (with the exception of hepatitis B immunoglobulins at birth).
- Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, Haemophilus influenzae type b and/or Streptococcus pneumoniae (with the exception of vaccines where the first dose can be given within the first two weeks of life).
- Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting 30 days before each dose of vaccine and ending 7 days after Dose 1 and Dose 2 and 30 days after Dose 3.
- History of, or intercurrent diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, H. influenzae type b and rotavirus disease.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- History of any neurological disorders or seizures.
- Major congenital defects or serious chronic illness.
- Acute disease at the time of enrolment.
- Gastroenteritis within 7 days preceding the study vaccine administration.
- Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract, intussusception or other medical condition determined to be serious by the investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (5)
GSK Investigational Site
Kuala Lumpur, 59100, Malaysia
GSK Investigational Site
Seremban, Negeri Sembilan, 70300, Malaysia
GSK Investigational Site
Singapore, 119074, Singapore
GSK Investigational Site
Singapore, 149547, Singapore
GSK Investigational Site
Singapore, 229899, Singapore
Related Publications (1)
Lim FS, Koh MT, Tan KK, Chan PC, Chong CY, Shung Yehudi YW, Teoh YL, Shafi F, Hezareh M, Swinnen K, Borys D. A randomised trial to evaluate the immunogenicity, reactogenicity, and safety of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) co-administered with routine childhood vaccines in Singapore and Malaysia. BMC Infect Dis. 2014 Oct 2;14:530. doi: 10.1186/1471-2334-14-530.
PMID: 25278086DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 11, 2008
First Posted
December 15, 2008
Study Start
January 5, 2009
Primary Completion
November 2, 2009
Study Completion
November 2, 2009
Last Updated
August 17, 2018
Results First Posted
November 19, 2010
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.