Study to Evaluate the Safety and Immunogenicity of a 10-valent Pneumococcal Conjugate Vaccine in Preterm Infants - Full Text View

Purpose

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)

Condition	Intervention	Phase
Pneumococcal Disease	Biological: Pneumococcal conjugate vaccine GSK1024850A Biological: Infanrix hexa	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Assess Safety/Immunogenicity of GSK Biologicals 10-valent Pneumococcal Conjugate Vaccine When Co-administered With DTPa-HBV-IPV/Hib Vaccine in Preterm Infants as a 3-dose Primary Immunization Course During the First 6 Months of Life

Resource links provided by NLM:

MedlinePlus related topics: Diphtheria Hepatitis Hepatitis B Premature Babies Tetanus

Drug Information available for: Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Occurrence of core fever >39°C (rectal temperature) or >38.5°C (oral, axillary or tympanic temperature). [ Time Frame: Within 4 days after at least one vaccination. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Occurrence of solicited local symptoms [ Time Frame: Within 4 days after each vaccination ] [ Designated as safety issue: No ]
Occurrence of solicited general symptoms [ Time Frame: Within 4 days after each vaccination ] [ Designated as safety issue: No ]
Occurrence of unsolicited adverse events [ Time Frame: Within 31 days after each vaccination. ] [ Designated as safety issue: Yes ]
Occurrence of serious adverse events [ Time Frame: Throughout the active phase of the study ] [ Designated as safety issue: Yes ]
Occurrence of serious adverse events [ Time Frame: During the extended safety follow-up . ] [ Designated as safety issue: Yes ]
Concentrations of antibodies against vaccine pneumococcal serotypes [ Time Frame: One month after the administration of the 3rd dose of the primary vaccination course with pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-HBV-IPV/Hib vaccine ] [ Designated as safety issue: No ]
Opsonophagocytic activity against vaccine pneumococcal serotypes. [ Time Frame: One month after the administration of the 3rd dose of the primary vaccination course with pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-HBV-IPV/Hib vaccine ] [ Designated as safety issue: No ]
Concentrations of antibodies against cross-reactive pneumococcal serotypes [ Time Frame: One month after the administration of the 3rd dose of the primary vaccination course with pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-HBV-IPV/Hib vaccine. ] [ Designated as safety issue: No ]
Opsonophagocytic activity against cross-reactive pneumococcal serotypes [ Time Frame: One month after the administration of the 3rd dose of the primary vaccination course with pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-HBV-IPV/Hib vaccine ] [ Designated as safety issue: No ]
Concentrations of antibodies against protein D. [ Time Frame: One month after the administration of the 3rd dose of the primary vaccination course with pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-HBV-IPV/Hib vaccine ] [ Designated as safety issue: No ]
Anti-diphtheria and anti-tetanus toxoids, anti-, anti-Pertussis, anti-Hepatitis B antibody concentrations, and anti-polio type 1, 2 and 3 antibody titres. [ Time Frame: One month after the administration of the 3rd dose of the primary vaccination course with pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-HBV-IPV/Hib vaccine ] [ Designated as safety issue: No ]

Enrollment:	286
Study Start Date:	October 2006
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Group A Very pretem infants born after a gestation period of 27-30 weeks (189-216 days)	Biological: Pneumococcal conjugate vaccine GSK1024850A Intramuscular injection, 3 doses Biological: Infanrix hexa Intramuscular injection, 3 doses Other Name: DTPa-HBV-IPV/Hib
Experimental: Group C Infants born after a gestation period of more than 36 weeks (more than 258 days)	Biological: Pneumococcal conjugate vaccine GSK1024850A Intramuscular injection, 3 doses Biological: Infanrix hexa Intramuscular injection, 3 doses Other Name: DTPa-HBV-IPV/Hib
Experimental: Group B Mild pretem infants born after a gestation period of 31-36 weeks (217-258 days)	Biological: Pneumococcal conjugate vaccine GSK1024850A Intramuscular injection, 3 doses Biological: Infanrix hexa Intramuscular injection, 3 doses Other Name: DTPa-HBV-IPV/Hib

Detailed Description:

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Eligibility

Ages Eligible for Study:	8 Weeks to 16 Weeks
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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).

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00390910

Locations

Greece
GSK Investigational Site
Athens, Greece, 115 27
GSK Investigational Site
Athens, Greece, 11527
GSK Investigational Site
Ioannina, Greece, 452 21
GSK Investigational Site
Rio/Patras, Greece, 26500
GSK Investigational Site
Thessaloniki, Greece, 54636
Spain
GSK Investigational Site
Burgos, Spain, 09005
GSK Investigational Site
Madrid, Spain, 28047
GSK Investigational Site
Móstoles/Madrid, Spain, 28935

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Omeñaca F, Merino JM, Tejedor JC, Constantopoulos A, Papaevangelou V, Kafetzis D, Tsirka A, Athanassiadou F, Anagnostakou M, François N, Borys D, Schuerman L. Immunization of preterm infants with 10-valent pneumococcal conjugate vaccine. Pediatrics. 2011 Aug;128(2):e290-8. Epub 2011 Jul 4.

Responsible Party:	Study Director, GSK
ClinicalTrials.gov Identifier:	NCT00390910 History of Changes
Other Study ID Numbers:	107737
Study First Received:	October 20, 2006
Last Updated:	September 25, 2009
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by GlaxoSmithKline:

Pneumococcal disease
Pneumococcal vaccine
Preterm
Safety
Immunogenicity

ClinicalTrials.gov processed this record on May 23, 2013