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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Infections, Streptococcal

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00466947

109563

2011-002076-16 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23,802 patients

Sex: All

Ages: 6 to 16 weeks old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

23,802 participants in 2 patient groups

Synflorix Group

Experimental group

Description:

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).

Treatment:

Biological: Infanrix hexa

Biological: Pneumococcal conjugate vaccine GSK1024850A

Biological: GSK Biologicals' DTPa-IPV/Hib vaccine

Biological: Havrix

Control Group

Active Comparator group

Description:

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.

Treatment:

Biological: GSK Biologicals' DTPa-IPV/Hib vaccine

Biological: Engerix-B

Biological: Havrix