Study to Evaluate the Safety and Immunogenicity of a 10-valent Pneumococcal Conjugate Vaccine in Preterm Infants
Study to Assess the Safety and Immunogenicity of GSK Biologicals 10-valent Pneumococcal Conjugate Vaccine When Co-administered With DTPa-HBV-IPV/Hib (Infanrix-Hexa) Vaccine in Preterm Infants as a 3-dose Primary Immunization Course During the First 6 Months of Life.
1 other identifier
interventional
286
2 countries
8
Brief Summary
This study aims to evaluate the safety, reactogenicity and immunogenicity of GlaxoSmithKline (GSK) Biologicals´ 10-valent pneumococcal conjugate vaccine when co-administered with diphtheria, tetanus, acellular pertussis-hepatitis B virus-inactivated polio virus/Haemophilus influenzae type b (DTPa-HBV-IPV/Hib) vaccine in preterm infants as a 3-dose primary immunization course during the first 6 months of life. This protocol posting deals with objectives \& outcome measures of the primary study. The objectives \& outcome measures of the Booster study are presented in a separate protocol posting (NCT number = 00609492)
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 Oct 2006
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 20, 2006
CompletedFirst Posted
Study publicly available on registry
October 23, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 2, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 2, 2008
CompletedResults Posted
Study results publicly available
December 17, 2018
CompletedDecember 17, 2018
May 1, 2017
9 months
October 20, 2006
May 5, 2017
June 5, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Subjects With Core Fever (Rectal Temperature) Greater Than (>) the Cut-off
Fever was measured as rectal temperature. Assessment of occurrences of fever \> 39.0 °C was performed post doses 1, 2 and 3 of Synflorix or Infanrix hexa vaccine.
Within 4 days (Days 0-3) after each vaccine dose, administered according to a 3-dose schedule at 2-4-6 months of age (Month 0-2-4)
Secondary Outcomes (28)
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Within 4 days (Days 0-3) after each vaccine dose, administered according to a 3-dose schedule at 2-4-6 months of age (Month 0-2-4)
Number of Subjects With Any and Grade 3 Solicited General Symptoms
Within 4 days (Days 0-3) after each vaccine dose, administered according to a 3-dose schedule at 2-4-6 months of age (Month 0-2-4)
Number of Subjects With Any Unsolicited Adverse Events (AEs)
Within 31 days (Days 0-30) after each vaccine dose, administered according to a 3-dose schedule at 2-4-6 months of age (Month 0-2-4)
Number of Subjects With Any Serious Adverse Events (SAEs)
Throughout the active phase of the study (from the first vaccine administration (Month 0) up to 1 month after the third vaccine administration (Month5).
Number of Subjects With Any Serious Adverse Events (SAEs)
Throughout the entire study period starting from the first vaccine dose administration (Month 0) up to the end of the 6-month safety follow-up (ESFU- Month 10).
- +23 more secondary outcomes
Study Arms (3)
Synflorix™ + Infanrix™ hexa Group I
EXPERIMENTALVery preterm infants born after a gestation period of 27-30 weeks (189-216 days)
Synflorix™ + Infanrix™ hexa Group II
EXPERIMENTALMild pretem infants born after a gestation period of 31-36 weeks (217-258 days)
Synflorix™ + Infanrix™ hexa Group III
EXPERIMENTALInfants born after a gestation period of more than 36 weeks (more than 258 days)
Interventions
Intramuscular injection, 3 doses
Intramuscular injection, 3 doses
Eligibility Criteria
You may qualify if:
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol
- A male or female between, and including, 8-16 weeks (56-118 days) of age at the time of the first vaccination.
- Written informed consent obtained from the parent or guardian of the subject.
- Born after a gestation period of \>27 weeks (at least 189 days).
- If full term born, healthy subjects as established by medical history and clinical examination before entering into the study
- If premature, medically stable condition (not requiring significant medical support or ongoing management for debilitating disease and having demonstrated a clinical course of sustained recovery).
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 study vaccines, or planned use during the study period
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs from birth to the first vaccine dose.
- Planned administration/administration of a vaccine not foreseen by the study protocol, during the period starting from one month before the first dose of vaccines and up to Visit 6.
- Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, Neisseria meningitidis and/or Streptococcus pneumoniae with the exception of vaccines where the first dose can be given within the first two weeks of life according to the national recommendations
- History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, Haemophilus influenzae type b disease, Neisseria meningitidis.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- History of any neurologic disorders or seizures (this criterion does not apply to subjects who have had a single, uncomplicated febrile convulsion in the past).
- Acute disease at the time of enrolment.
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination
- A family history of congenital or hereditary immunodeficiency.
- Major congenital defects or serious chronic illness.
- Administration of immunoglobulins, with the exception of monoclonal antibodies against RSV, and/or any blood products within one month preceding the first dose of study vaccines or planned administration during the active phase of the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (8)
GSK Investigational Site
Athens, 115 27, Greece
GSK Investigational Site
Athens, 11527, Greece
GSK Investigational Site
Ioannina, 452 21, Greece
GSK Investigational Site
Rio/Patras, 26500, Greece
GSK Investigational Site
Thessaloniki, 54636, Greece
GSK Investigational Site
Burgos, 09005, Spain
GSK Investigational Site
Madrid, 28047, Spain
GSK Investigational Site
Móstoles/Madrid, 28935, Spain
Related Publications (3)
Omenaca F, Merino JM, Tejedor JC, Constantopoulos A, Papaevangelou V, Kafetzis D, Tsirka A, Athanassiadou F, Anagnostakou M, Francois N, Borys D, Schuerman L. Immunization of preterm infants with 10-valent pneumococcal conjugate vaccine. Pediatrics. 2011 Aug;128(2):e290-8. doi: 10.1542/peds.2010-1184. Epub 2011 Jul 4.
PMID: 21727108BACKGROUNDOmeneca F et al. Vaccination of pre-term infants with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHID-CV). Abstract presented at the 27th annual ESPID meeting, Brussels, Belgium, 9-13 June 2009.
BACKGROUNDOmeneca F et al. Immunogenicity and safety of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) following primary and booster vaccination in preterm-born children. Abstract presented at Excellence In Paediatrics. Florence, Italy, 3-6 December 2009.
BACKGROUND
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
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 20, 2006
First Posted
October 23, 2006
Study Start
October 1, 2006
Primary Completion
July 2, 2007
Study Completion
May 2, 2008
Last Updated
December 17, 2018
Results First Posted
December 17, 2018
Record last verified: 2017-05
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.