Long-term Follow-up Study of Children Previously Primed With GSK Pneumococcal Vaccine (GSK1024850A) and of Unprimed Children

NCT00950833 | Completed Phase 3 Results

• 1 other identifier: 112801
• Study Type: interventional
• Target: 466
• Locations: 1 country
• Sites: 10

Brief Summary

The objective of this study is to evaluate the immune memory through the administration of an additional dose of GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A, the antibody persistence and long-term effect on nasopharyngeal carriage of S. pneumoniae and H. influenzae in subjects primed and boosted with GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A in previous primary and booster studies. For subjects that did not receive the investigational vaccine during the primary and booster study, the objective is to evaluate immunogenicity, safety and reactogenicity of a 2-dose catch-up vaccination with GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A. This protocol posting deals with objectives \& outcome measures of the extension phase. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT00370318). The objectives \& outcome measures of the booster phase are presented in a separate protocol posting (NCT00496015).

Conditions

Infections, Streptococcal

Keywords

Catch-up vaccination; Pneumococcal vaccine; Immune memory; Nasopharyngeal carriage; Immunogenicity; Pneumococcal disease; Safety

Outcome Measures

Primary Outcomes (1)

• Antibody Concentrations Against Vaccine Pneumococcal Serotypes

  Antibody concentrations against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) have been assessed by 22F-inhibition enzyme linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.05 μg/mL.

  At 7-10 days after the first vaccine dose

Secondary Outcomes (26)

• Antibody Concentrations Against Vaccine Pneumococcal Serotypes

  Prior to the first study vaccine dose (At Day 0)

• Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes

  Prior to (Day 0) and 7-10 days after the first vaccine dose

• Antibody Concentrations Against Vaccine Pneumococcal Cross-reactive Serotypes 6A and 19A

  Prior to (Day 0) and 7-10 days after the first vaccine dose

• Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A

  Prior to (Day 0) and 7-10 days after the first vaccine dose

• Antibody Concentrations Against Protein D (Anti-PD)

  Prior to (Day 0) and 7-10 days after the first vaccine dose

Study Arms (3)

AP-AP Group

ACTIVE COMPARATOR

subjects from the AP-AP group, previously vaccinated with pneumococcal conjugate vaccine GSK1024850A in study NCT00496015, receiving an additional dose of pneumococcal conjugate vaccine GSK1024850A for immune memory assessment

Biological: Pneumococcal vaccine GSK1024850A

NAP-pre Group

ACTIVE COMPARATOR

subjects from the NAP-pre group, previously vaccinated with pneumococcal conjugate vaccine GSK1024850A in study NCT00496015 receiving an additional dose of pneumococcal conjugate vaccine GSK1024850A for immune memory assessment

Biological: Pneumococcal vaccine GSK1024850A

Unprimed Group

ACTIVE COMPARATOR

Age-matched subjects from the unprimed group of the NCT00496015 study, not previously vaccinated with any pneumococcal vaccine, receiving two doses of pneumococcal conjugate vaccine GSK1024850A

Biological: Pneumococcal vaccine GSK1024850A

Interventions

Pneumococcal vaccine GSK1024850A BIOLOGICAL

1 or 2 intramuscular injections

AP-AP Group; NAP-pre Group; Unprimed Group

Eligibility Criteria

• Age: 31 Months - 44 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, 31 and 34 months of age at the time of the enrolment.
• Subjects who previously participated in study NCT00496015
• For the subjects in the primed AP-AP and NAP-pre groups: subjects who received a booster dose of the pneumococcal conjugate vaccine prior to the study amendment 3.
• For the subjects in the unprimed group: subjects who received a dose of the meningococcal vaccine GSK134612.
• 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 product (drug or vaccine) other than the study vaccine within 30 days preceding enrolment, or planned use during the entire study period.
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the entire study period.
• Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of study vaccine and ending 30 days after.
• Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• History of seizures or progressive neurological disease.
• Acute disease at the time of enrolment, defined as the presence of a mild, moderate or severe illness with or without fever.
• Administration or planned use of immunoglobulins and/ or any blood products during the entire study period.
• A family history of congenital or hereditary immunodeficiency.
• Major congenital defects or serious chronic illness.
• Subjects of which both parents have a history of atopia (polinosis, asthma, atopic eczema).
• Administration of any pneumococcal vaccine since the end of study NCT00496015.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (10)

GSK Investigational Site

Brno, 628 00, Czechia

Location

GSK Investigational Site

Hradec Králové, 500 01, Czechia

Location

GSK Investigational Site

Jindřichův Hradec, 377 01, Czechia

Location

GSK Investigational Site

Náchod, 547 01, Czechia

Location

GSK Investigational Site

Ostrava, 70800, Czechia

Location

GSK Investigational Site

Pardubice, 532 03, Czechia

Location

GSK Investigational Site

Prague, 150 00, Czechia

Location

GSK Investigational Site

Prague, 160 00, Czechia

Location

GSK Investigational Site

Prague, 190 00, Czechia

Location

GSK Investigational Site

Znojmo, 669 00, Czechia

Location

Related Publications (4)

• Prymula R, Habib A, Francois N, Borys D, Schuerman L. Immunological memory and nasopharyngeal carriage in 4-year-old children previously primed and boosted with 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) with or without concomitant prophylactic paracetamol. Vaccine. 2013 Apr 12;31(16):2080-8. doi: 10.1016/j.vaccine.2013.01.044. Epub 2013 Feb 5.

  PMID: 23391599 BACKGROUND

• Prymula R et al. Immune memory 2-3 years after vaccination with pneumococcal non-typeable Heamophilus influenzae protein-D conjugate vaccine (PHiD-CV), with or without prophylactic paracetamol. Abstract presented at the 30th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID), Thessaloniki, Greece, 8-12 May 2012.

  BACKGROUND

• Prymula R et al. Long-term effect of 10-valent pneumococcal non-typeable Haemophilus Influenzae protein D conjugate vaccine (PHiD-CV) on nasopharyngeal bacterial carriage in Czech children. Abstract presented at the 8th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD), Iguaçu Falls, Brazil, 11-15 March, 2012.

  BACKGROUND

• Silfverdal SA et al. Immunogenicity and reactogenicity of 2-dose catch-up vaccination with 10-valent pneumococcal non-typeable Haemophilus Influenzae protein D conjugate vaccine (PHiD-CV) during the fourth year of life. Abstract presented at the 8th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD), Iguaçu Falls, Brazil, 11-15 March, 2012.

  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

Condition Hierarchy (Ancestors)

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

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: July 30, 2009
• First Posted: August 3, 2009
• Study Start: August 10, 2009
• Primary Completion: September 16, 2010
• Study Completion: October 27, 2010
• Last Updated: September 20, 2018
• Results First Posted: August 7, 2017

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share

Locations

CZ (10)