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

NCT ID: NCT00466947

Last Updated: 2019-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 23802 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-28
• Study Completion Date: 2011-07-28

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.

Detailed Description

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007. The following vaccines will be offered by the sponsor:

• Two doses of hepatitis A vaccine will be offered to all subjects to comply with national recommendations.
• NeisVac-C vaccine against Neisseria meningitis group C will be offered to all subjects in Argentina at 12 months of age.
• Varicella vaccine will be offered to all subjects in Colombia and Panama at 12 months of age.
• Two doses of Rotarix vaccine will be offered to all subjects in Colombia within the first six months of life.

In addition, all subjects will receive a dose of Hepatitis B vaccine at birth according to national recommendations and a dose of measles, mumps and rubella (MMR) vaccine at 12 to 15 months of age according to local Extended Program of Immunization (EPI) .

These vaccines will not be provided by the sponsor. The protocol posting has been updated according to the amendment of the protocol dated 25 Nov 2008. The protocol posting has been updated according to the amendment of the protocol dated 14 December 2009. The protocol posting has been updated according to the amendment of the protocol dated 09 September 2010.

Conditions

Infections, Streptococcal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Synflorix Group

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).

Group Type: EXPERIMENTAL

Pneumococcal conjugate vaccine GSK1024850A

Intervention Type: BIOLOGICAL

Intramuscular injection, 4 doses

Havrix

Intervention Type: BIOLOGICAL

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

Infanrix hexa

Intervention Type: BIOLOGICAL

Intramuscular injection,3 doses

GSK Biologicals' DTPa-IPV/Hib vaccine

Intervention Type: BIOLOGICAL

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

Control Group

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.

Group Type: ACTIVE_COMPARATOR

Havrix

Intervention Type: BIOLOGICAL

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

Engerix-B

Intervention Type: BIOLOGICAL

Intramuscular injection, 3 doses

GSK Biologicals' DTPa-IPV/Hib vaccine

Intervention Type: BIOLOGICAL

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

Interventions

Pneumococcal conjugate vaccine GSK1024850A

Intramuscular injection, 4 doses

Intervention Type: BIOLOGICAL

Havrix

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

Intervention Type: BIOLOGICAL

Engerix-B

Intramuscular injection, 3 doses

Intervention Type: BIOLOGICAL

Infanrix hexa

Intramuscular injection,3 doses

Intervention Type: BIOLOGICAL

GSK Biologicals' DTPa-IPV/Hib vaccine

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

Intervention Type: BIOLOGICAL

Other Intervention Names

Hepatitis A vaccine; Hepatitis B vaccine; DTPa-HBV-IPV/Hib

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 6 Weeks
• Maximum Eligible Age: 16 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Godoy Cruz, Mendoza Province, Argentina

GSK Investigational Site

Las Heras, Mendoza Province, Argentina

GSK Investigational Site

Luján de Cuyo, Mendoza Province, Argentina

GSK Investigational Site

Villa Nueva, Mendoza Province, Argentina

GSK Investigational Site

Villanueva, Mendoza Province, Argentina

GSK Investigational Site

Albardón, San Juan Province, Argentina

GSK Investigational Site

Caucete, San Juan Province, Argentina

GSK Investigational Site

Fernández, Santiago del Estero Province, Argentina

GSK Investigational Site

La Banda, Santiago del Estero Province, Argentina

GSK Investigational Site

Córdoba, , Argentina

GSK Investigational Site

La Banda, , Argentina

GSK Investigational Site

Maipú, , Argentina

GSK Investigational Site

Mendoza, , Argentina

GSK Investigational Site

San Juan, , Argentina

GSK Investigational Site

San Juan, , Argentina

GSK Investigational Site

San Juan, , Argentina

GSK Investigational Site

San Martín, , Argentina

GSK Investigational Site

Santiago del Estero, , Argentina

GSK Investigational Site

Santiago del Estero, , Argentina

GSK Investigational Site

Santiago del Estero, , Argentina

GSK Investigational Site

Cali, , Colombia

GSK Investigational Site

Panama City, , Panama

Countries

Argentina; Colombia; Panama

References

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.

Reference Type: BACKGROUND

PMID: 26954689 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28368738 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24892763 (View on PubMed)

Study Documents

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

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Other Identifiers

2011-002076-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

109563

Identifier Type: -

Identifier Source: org_study_id