Evaluate Safety and Immunogenicity of a Booster Dose of Pneumococcal Conjugate Vaccine in Preterm Born Infants.

NCT00609492 | Completed Phase 3 Results

• 2 other identifiers: 1096212007-000596-42
• Study Type: interventional
• Target: 245
• Locations: 2 countries
• Sites: 7

Brief Summary

The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of a booster dose of GlaxoSmithKline (GSK) Biologicals´ pneumococcal conjugate vaccine co-administered with a booster dose of DTPa-IPV/Hib (Infanrix-IPV/Hib) in preterm born children at the age of 16-18 months. This protocol posting deals with objectives \& outcome measures of the booster phase. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number =NCT00390910 ). Subjects participating in this study should have received three doses of pneumococcal vaccine in the primary study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions

Infections, Streptococcal; Streptococcus Pneumoniae Vaccines

Outcome Measures

Primary Outcomes (1)

• Number of Subjects Reporting Fever With Rectal Temperature Above (>) 39.0 Degrees Celsius (°C)

  Fever was measured as rectal temperature. Assessment of occurrences of fever \> 39.0 °C was performed within 4-days (Day 0-3) after booster vaccination of Synflorix™ and Infanrix™-IPV/Hib vaccine.

  Within 4-days (Day 0-3) after booster vaccination

Secondary Outcomes (27)

• Number of Subjects With Any and Grade 3 Solicited Local Symptoms

  Within 4-days (Day 0-3) after booster vaccination

• Number of Subjects With Any and Grade 3 Solicited General Symptoms

  Within 4-days (Day 0-3) after booster vaccination

• Number of Subjects With Unsolicited Adverse Events (AEs)

  Within 31-days (Day 0-30) after booster vaccination

• Number of Subjects With Serious Adverse Events (SAEs)

  Throughout the active phase of the study (Month 0 to Month 1)

• Number of Subjects With Serious Adverse Events (SAEs)

  Throughout the entire study period starting from Month 0 up to the end of the extended safety follow-up (Month 6)

Study Arms (3)

Preterm I Group

EXPERIMENTAL

Children born after a gestation period of 27-30 weeks

Biological: GSK Biologicals´ Pneumococcal Conjugate Vaccine (GSK1024850A); Biological: Infanrix™-IPV/Hib

Preterm II Group

EXPERIMENTAL

Children born after a gestation period of 31-36 weeks

Biological: GSK Biologicals´ Pneumococcal Conjugate Vaccine (GSK1024850A); Biological: Infanrix™-IPV/Hib

Full term Group

ACTIVE COMPARATOR

Children born after a gestation period of more than 36 weeks

Biological: GSK Biologicals´ Pneumococcal Conjugate Vaccine (GSK1024850A); Biological: Infanrix™-IPV/Hib

Interventions

GSK Biologicals´ Pneumococcal Conjugate Vaccine (GSK1024850A) BIOLOGICAL

Single dose, intramuscular injection

Full term Group; Preterm I Group; Preterm II Group

Infanrix™-IPV/Hib BIOLOGICAL

Single dose, intramuscular injection

Full term Group; Preterm I Group; Preterm II Group

Eligibility Criteria

• Age: 16 Months - 18 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
• A male or female between, and including, 16-18 months of age at the time of the booster vaccination.
• A male or female who previously participated in study 107737 and received three doses of pneumococcal conjugate vaccine.
• Written informed consent obtained from the parent or guardian of the subject.
• Free of obvious health problems as established by medical history and clinical examination before entering into the study.

You may not qualify if:

• Concurrently participating in another clinical study, at any time during the study period (active phase and extended safety follow-up), in which the subject has been or will be exposed to an investigational or a non-investigational product.
• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the booster dose of study vaccines, or planned use during the study period (active phase and 5 months extended safety follow-up).
• Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to the booster dose of study vaccine.
• Planned administration/administration of a vaccine not foreseen by the study protocol, during the period starting from one month (30 days) before the booster dose of study vaccines (Visit 1) and up to the follow-up visit (Visit 2).
• Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b and/or Streptococcus pneumoniae other than the study vaccines from study 107737
• History of or intercurrent diphtheria, tetanus, hepatitis B, pertussis, polio, Haemophilus influenzae type b disease.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
• History of seizures or progressive neurological disease
• Acute disease at the time of enrolment.
• Febrile illness defined as oral, axillary or tympanic temperature \< 37.5°C / rectal temperature \< 38°C. A temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject.
• 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 three months preceding the booster dose of study vaccines or planned administration during the active phase of the study.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (7)

GSK Investigational Site

Athens, 115 27, Greece

Location

GSK Investigational Site

Athens, 11527, Greece

Location

GSK Investigational Site

Ioannina, 452 21, Greece

Location

GSK Investigational Site

Thessaloniki, 54636, Greece

Location

GSK Investigational Site

Burgos, 09005, Spain

Location

GSK Investigational Site

Madrid, 28047, Spain

Location

GSK Investigational Site

Móstoles/Madrid, 28935, Spain

Location

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: 21727108 BACKGROUND

• Omenaca F et al. Booster vaccination of preterm-born children with 10-valent pneumococcal non-typeable haemophilus influenzae protein D-conjugate vaccine (PHiD-CV): antibody responses and safety. Abstract presented at the 6th World Congress of the World Society for Pediatric Infectious Diseases (WSPID). Beunos Aires, Argentina, 18-22 November 2009.

  BACKGROUND

• Omenaca 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

• 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

Streptococcal Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Limitations and Caveats

None reported.

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 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2008
• First Posted: February 7, 2008
• Study Start: January 3, 2008
• Primary Completion: November 10, 2008
• Study Completion: March 30, 2009
• Last Updated: January 3, 2020
• Results First Posted: April 12, 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

ES (3); GR (4)