COMPAS (Clinical Otitis Media & Pneumonia Study): Pneumonia & Acute Otitis Media (AOM ) Efficacy Study of the Pneumococcal Conjugate Vaccine

NCT00466947 | Completed Phase 3 Results

• 2 other identifiers: 1095632011-002076-16
• Study Type: interventional
• Target: 23,802
• Locations: 3 countries
• Sites: 22

Brief Summary

This is a study in a large number of healthy children less than 3 years old to measure the efficacy of GlaxoSmithKline (GSK) Biologicals' 10-valent pneumococcal conjugate candidate vaccine (Synflorix vaccine, or GSK1024850A) to prevent cases of pneumonia (lung infection) likely caused by bacteria (Streptococcus pneumoniae and Haemophilus influenzae) or cases of otitis media (ear infection) in children under 3 years old.

Conditions

Infections, Streptococcal

Keywords

Otitis media; Pneumonia; Community acquired pneumonia (CAP); Pneumococcal disease; Booster vaccination; Immunogenicity; Pneumococcal vaccine; Safety; Efficacy; Carriage

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With a First Episode Reported of Bacterial Community Acquired Pneumoniae (B-CAP)

  A B-CAP episode was defined as a radiologically confirmed community acquired pneumoniae (CAP) episode with either alveolar consolidation/pleural effusion on the chest X-ray (CXR) or with non-alveolar infiltrates but with C reactive protein (CRP) higher than or equal to (\>=) 40 milligrams per liter (mg/L). The results are presented for data lock point for the primary outcome analysis (31 August 2010), which was performed, as per protocol, when at least 535 first B-CAP episodes were reported from 2 weeks after the third vaccination dose. After analysis on primary outcome was performed, re-monitoring activities revealed Informed Consent Form issues for some subjects. Therefore, a sensitivity analysis excluding 144 subjects was performed. This analysis confirmed the validity of the results for primary outcome.

  Any time from 2 weeks after Dose 3 up to 31 August 2010

Secondary Outcomes (61)

• Number of Subjects With Serious Adverse Events (SAEs)

  Throughout the study (Month 0 to Month 22-25)

• Number of Subjects With Any Unsolicited Adverse Event (AE), in the Panama Subset

  Throughout the study (Month 0 to Month 22-25)

• Number of Subjects With Solicited Local Symptoms Post Primary Vaccination in the Immunogenicity and Tolerability Subset

  Within the 4-days (Days 0-3) follow-up period across the 3 doses of the primary study vaccine administration

• Number of Subjects With Solicited Local Symptoms Post Booster Vaccination in the Immunogenicity and Tolerability Subset

  Within the 4-days (Days 0-3) follow-up period following the booster vaccine administration

• Number of Subjects With Solicited Local Symptoms Post Primary Vaccination in the Immunogenicity and Tolerability Subset

  Within the 4-days (Days 0-3) follow-up period across the 3 doses of the primary study vaccine administration

Study Arms (2)

Synflorix Group

EXPERIMENTAL

Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).

Biological: Pneumococcal conjugate vaccine GSK1024850A; Biological: Havrix; Biological: Infanrix hexa; Biological: GSK Biologicals' DTPa-IPV/Hib vaccine

Control Group

ACTIVE COMPARATOR

Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.

Biological: Havrix; Biological: Engerix-B; Biological: GSK Biologicals' DTPa-IPV/Hib vaccine

Interventions

Pneumococcal conjugate vaccine GSK1024850A BIOLOGICAL

Intramuscular injection, 4 doses

Synflorix Group

Havrix BIOLOGICAL

Intramuscular injection, 2 doses in Synflorix group and 3 doses in Control group

Also known as: Hepatitis A vaccine

Control Group; Synflorix Group

Engerix-B BIOLOGICAL

Intramuscular injection, 3 doses

Also known as: Hepatitis B vaccine

Control Group

Infanrix hexa BIOLOGICAL

Intramuscular injection,3 doses

Also known as: DTPa-HBV-IPV/Hib

Synflorix Group

GSK Biologicals' DTPa-IPV/Hib vaccine BIOLOGICAL

Intramuscular injection, 1 dose in Synflorix group and 4 doses in Control group

Control Group; Synflorix Group

Eligibility Criteria

• Age: 6 Weeks - 16 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• A male or female between, and including, 6 and 16 weeks of age at the time of the first vaccination. Pre-term born infants can be included in the study starting from 8 weeks of chronological age at the time of first vaccination and up to 16 weeks of chronological age
• Subjects should be living in the area covered by the surveillance system for community acquired pneumonia (CAP), invasive disease and acute otitis media (AOM) •Written informed consent obtained from the parent or guardian of the subject.
• Free of any known or suspected health problems (as established by medical history and clinical examination before entering into the study), that would contraindicate the initiation of routine immunizations outside a clinical trial context.
• Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol

You may not qualify if:

• Use of any investigational or non-registered drug or planned use during the study period.
• Use or planned use of any investigational or non-registered vaccine other than the study vaccine(s).
• Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae type b, hepatitis A and/or Streptococcus. pneumoniae . Locally recommended EPI vaccines to be given at birth are allowed, but should be administered at least one month before the first dose of the study vaccine .Other locally recommended vaccines are always allowed, even if concomitantly administered with the study vaccines. •Previous or planned vaccination with a registered pneumococcal vaccine such as Prevnar is not allowed. If Prevnar immunization needs to be initiated, due to the presence of a high risk disease for pneumococcal infections for which the Prevnar vaccine is made locally available, the subject can not be enrolled in the study and should be referred to the specific Prevnar immunization program.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
• History of any neurologic disorders or seizures.
• Acute disease at the time of enrolment
• For Colombia: infants with low birth weight ( less than (\<) 2.500 grams)

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (22)

GSK Investigational Site

Godoy Cruz, Mendoza Province, Argentina

Location

GSK Investigational Site

Las Heras, Mendoza Province, Argentina

Location

GSK Investigational Site

Luján de Cuyo, Mendoza Province, Argentina

Location

GSK Investigational Site

Villa Nueva, Mendoza Province, Argentina

Location

GSK Investigational Site

Villanueva, Mendoza Province, Argentina

Location

GSK Investigational Site

Albardón, San Juan Province, Argentina

Location

GSK Investigational Site

Caucete, San Juan Province, Argentina

Location

GSK Investigational Site

Fernández, Santiago del Estero Province, 4200, Argentina

Location

GSK Investigational Site

La Banda, Santiago del Estero Province, 4300, Argentina

Location

GSK Investigational Site

Córdoba, 5000, Argentina

Location

GSK Investigational Site

La Banda, 4300, Argentina

Location

GSK Investigational Site

Maipú, Argentina

Location

GSK Investigational Site

Mendoza, 5500, Argentina

Location

GSK Investigational Site

San Juan, 5400, Argentina

Location

GSK Investigational Site

San Juan, 5425, Argentina

Location

GSK Investigational Site

San Juan, Argentina

Location

GSK Investigational Site

San Martín, Argentina

Location

GSK Investigational Site

Santiago del Estero, 4200, Argentina

Location

GSK Investigational Site

Santiago del Estero, 4300, Argentina

Location

GSK Investigational Site

Santiago del Estero, Argentina

Location

GSK Investigational Site

Cali, Colombia

Location

GSK Investigational Site

Panama City, Panama

Location

Related Publications (3)

• Silfverdal SA, Coremans V, Francois N, Borys D, Cleerbout J. Safety profile of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). Expert Rev Vaccines. 2017 Feb;16(2):109-121. doi: 10.1586/14760584.2016.1164044. Epub 2016 Sep 30.

  PMID: 26954689 BACKGROUND

• Saez-Llorens X, Rowley S, Wong D, Rodriguez M, Calvo A, Troitino M, Salas A, Vega V, Castrejon MM, Lommel P, Pascal TG, Hausdorff WP, Borys D, Ruiz-Guinazu J, Ortega-Barria E, Yarzabal JP, Schuerman L. Efficacy of 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine against acute otitis media and nasopharyngeal carriage in Panamanian children - A randomized controlled trial. Hum Vaccin Immunother. 2017 Jun 3;13(6):1-16. doi: 10.1080/21645515.2017.1287640. Epub 2017 Feb 25.

  PMID: 28368738 BACKGROUND

• Tregnaghi MW, Saez-Llorens X, Lopez P, Abate H, Smith E, Posleman A, Calvo A, Wong D, Cortes-Barbosa C, Ceballos A, Tregnaghi M, Sierra A, Rodriguez M, Troitino M, Carabajal C, Falaschi A, Leandro A, Castrejon MM, Lepetic A, Lommel P, Hausdorff WP, Borys D, Ruiz Guinazu J, Ortega-Barria E, Yarzabal JP, Schuerman L; COMPAS Group. Efficacy of pneumococcal nontypable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in young Latin American children: A double-blind randomized controlled trial. PLoS Med. 2014 Jun 3;11(6):e1001657. doi: 10.1371/journal.pmed.1001657. eCollection 2014 Jun.

  PMID: 24892763 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; Otitis Media; Pneumonia; Community-Acquired Pneumonia; Pneumococcal Infections

Interventions

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

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Otitis; Ear Diseases; Otorhinolaryngologic Diseases; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Community-Acquired 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 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2007
• First Posted: April 27, 2007
• Study Start: June 28, 2007
• Primary Completion: August 31, 2010
• Study Completion: July 28, 2011
• Last Updated: July 16, 2019
• Results First Posted: September 4, 2013

Record last verified: 2019-07

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

AR (20); CO (1); PA (1)