Assess Reacto- and Immunogenicity of Pneumococcal Conjugate Vaccine When Given as Booster or a 2 Dose Catch up Schedule

NCT00513409 | Completed Phase 2 Results

• 1 other identifier: 110031
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 1

Brief Summary

This is a booster study in 2 groups of healthy children less than 3 years old to measure the reactogenicity, safety and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine, when given as a booster or as a two-dose catch-up vaccination. This protocol posting deals with objectives and outcome measures of the booster phase. The objectives and outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00338351).

Conditions

Infections, Streptococcal

Keywords

Immunogenicity; Pneumococcal disease; Safety; Booster vaccination; Pneumococcal vaccine

Outcome Measures

Primary Outcomes (1)

• Number of Subjects Reporting Grade 3 Symptoms (Solicited and Unsolicited)

  Grade 3 symptoms are symptoms which prevent normal, everyday activities (e.g. in a young child such symptom would prevent attendance at school/ kindergarten/ a day-care center and would cause the parents/guardians to seek medical advice).

  Within 4 days after the administration of any study vaccine dose

Secondary Outcomes (10)

• Number of Subjects Reporting Solicited Local Symptoms

  Within 4 days after the administration of any study vaccine dose

• Number of Subjects Reporting Solicited General Symptoms

  Within 4 days after the administration of any study vaccine dose

• Number of Subjects Reporting Unsolicited Adverse Events

  Within 31 days after the administration of any study vaccine dose

• Number of Subjects Reporting Serious Adverse Events During the Active Phase of the Study

  Throughout the active phase of the study ( from the beginning of the booster phase up to 1 month after the second booster dose)

• Number of Subjects Reporting Serious Adverse Events Throughout the Entire Study Period

  Throughout the entire study period (from the beginning of the booster phase up to the end of the 6-month extended safety follow-up)

Study Arms (2)

Synflorix Booster Group

EXPERIMENTAL

Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).

Biological: Synflorix; Biological: Infanrix Hexa; Biological: Havrix

Synflorix Catch-up Group

EXPERIMENTAL

Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).

Biological: Synflorix; Biological: Infanrix Hexa

Interventions

Synflorix BIOLOGICAL

Intramuscular injection, 1 or 2 doses

Synflorix Booster Group; Synflorix Catch-up Group

Infanrix Hexa BIOLOGICAL

1 Intramuscular injection

Also known as: DTPa-HBV-IPV/Hib

Synflorix Booster Group; Synflorix Catch-up Group

Havrix BIOLOGICAL

1 Intramuscular injection

Synflorix Booster Group

Eligibility Criteria

• Age: 18 Months - 21 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Male or female between, and including, 18-21 months of age at the time of vaccination.
• Subjects who previously participated in the primary study and received 3 doses of study or control vaccines during the primary study.
• Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
• 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:

• Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the booster doses of study vaccines, or planned use during the study period (active phase and extended safety follow-up).
• Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month (30 days) before the booster doses of vaccine(s) and during the active phase of the study (up to the follow-up visit (Visit 3)).
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
• History of seizures (subjects who have had a single, uncomplicated febrile convulsion in the past can be included) or progressive neurological disease.
• Acute disease at the time of enrolment.
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the booster doses of study vaccines.
• 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 and/or any blood products within the last 3 months prior to booster or follow-up vaccination or planned administration during the active phase of the study.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Santiago, Región Metro de Santiago, Chile

Location

Related Publications (2)

• Lagos RE, Munoz AE, Levine MM, Lepetic A, Francois N, Yarzabal JP, Schuerman L. Safety and immunogenicity of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Chilean children. Hum Vaccin. 2011 May;7(5):511-22. doi: 10.4161/hv.7.5.14634. Epub 2011 May 1.

  PMID: 21441782 BACKGROUND

• Lagos R et al. 10-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) given as booster dose or 2-dose catch-up in Chilean children. Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.

  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; Pneumococcal Infections

Interventions

PHiD-CV vaccine; diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine; Hepatitis A Vaccines

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Viral Hepatitis Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

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: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2007
• First Posted: August 8, 2007
• Study Start: August 22, 2007
• Primary Completion: February 20, 2008
• Study Completion: August 28, 2008
• Last Updated: December 19, 2018
• Results First Posted: August 11, 2009

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will share

Locations

CL (1)