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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00466947
First received: April 26, 2007
Last updated: June 20, 2013
Last verified: June 2013
Results First Received: August 25, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Caregiver, Investigator);   Primary Purpose: Prevention
Condition: Pneumonia & AOM Caused by S. Pneumoniae & H. Influenzae
Interventions: Biological: Pneumococcal conjugate vaccine GSK1024850A
Biological: Havrix
Biological: Engerix-B
Biological: Infanrix hexa
Biological: GSK Biologicals' DTPa-IPV/Hib vaccine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Analysis on the primary outcome was performed when at least 535 first bacterial CAP episodes were reported from 2 weeks after vaccine Dose 3 (31 August 2010) with 23738 subjects (11875 and 11863 in Synflorix and Control groups) and analysis at study end was performed on 23597 subjects.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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).
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 vaccine were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.

Participant Flow:   Overall Study
    Synflorix Group     Control Group  
STARTED     11798     11799  
COMPLETED     9302     9265  
NOT COMPLETED     2496     2534  
Adverse Event                 35                 43  
Lost to Follow-up                 1137                 1167  
Physician Decision                 29                 29  
Protocol Violation                 9                 17  
Withdrawal by Subject                 1264                 1267  
Other – Forbidden vaccination                 21                 10  
Other – Subject without a legal guardian                 1                 0  
Other – Unconformity in team’s treatment                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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).
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 vaccine were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
Total Total of all reporting groups

Baseline Measures
    Synflorix Group     Control Group     Total  
Number of Participants  
[units: participants]
  11798     11799     23597  
Age [1]
[units: Weeks]
Mean ± Standard Deviation
  9.2  ± 1.93     9.2  ± 1.92     9.2  ± 1.92  
Gender [1]
[units: Subjects]
     
Female     5796     5767     11563  
Male     6002     6032     12034  
Region of Enrollment [1]
[units: Subjects]
     
Argentina     6990     6991     13981  
Columbia     1206     1196     2402  
Panama     3602     3612     7214  
[1] Baseline measures presented below correspond to those of the subjects whose data were exploited towards analysis of results at the end of the study



  Outcome Measures
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1.  Primary:   Number of Subjects With a First Episode Reported of Bacterial Community Acquired Pneumoniae (B-CAP)   [ Time Frame: Any time from 2 weeks after Dose 3 up to 31 August 2010 ]

2.  Secondary:   Number of Subjects With Serious Adverse Events (SAEs)   [ Time Frame: Throughout the study (Month 0 to Month 22-25) ]

3.  Secondary:   Number of Subjects With Any Unsolicited Adverse Event (AE), in the Panama Subset   [ Time Frame: Throughout the study (Month 0 to Month 22-25) ]

4.  Secondary:   Number of Subjects With Solicited Local Symptoms Post Primary Vaccination in the Immunogenicity and Tolerability Subset   [ Time Frame: Within the 4-days (Days 0–3) follow-up period across the 3 doses of the primary study vaccine administration ]

5.  Secondary:   Number of Subjects With Solicited Local Symptoms Post Booster Vaccination in the Immunogenicity and Tolerability Subset   [ Time Frame: Within the 4-days (Days 0–3) follow-up period following the booster vaccine administration ]

6.  Secondary:   Number of Subjects With Solicited Local Symptoms Post Primary Vaccination in the Immunogenicity and Tolerability Subset   [ Time Frame: Within the 4-days (Days 0–3) follow-up period across the 3 doses of the primary study vaccine administration ]

7.  Secondary:   Number of Subjects With Solicited Local Symptoms Post Booster Vaccination in the Immunogenicity and Tolerability Subset, for the Control Group   [ Time Frame: Within the 4-days (Days 0–3) follow-up period following the booster vaccine administration. ]

8.  Secondary:   Number of Subjects With Solicited General Symptoms Post Primary Vaccination in the Immunogenicity and Tolerability Subset   [ Time Frame: Within the 4-days (Days 0–3) follow-up period across the 3 doses of the primary study vaccine administration ]

9.  Secondary:   Number of Subjects With Solicited General Symptoms Post Booster Vaccination in the Immunogenicity and Tolerability Subset   [ Time Frame: Within the 4-days (Days 0–3) follow-up period following the booster vaccine administration ]

10.  Secondary:   Number of Subjects With a First Episode Reported of Clinically Confirmed Acute Otitis Media (AOM) (C-AOM), in the Panama Subset   [ Time Frame: Any time from 2 weeks after Dose 3 to study end at Month 22-25 ]

11.  Secondary:   Number of Subjects With a First Episode Reported of Community Acquired Pneumoniae (CAP) With Alveolar Consolidation or Pleural Effusion on the Chest X-ray (CXR) (C-CAP)   [ Time Frame: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25 ]

12.  Secondary:   Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Any Bacterial Pathogen, in the Panama Subset   [ Time Frame: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25 ]

13.  Secondary:   Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Streptococcus Pneumoniae (S. pn.) Vaccine Serotypes, in the Panama Subset   [ Time Frame: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25 ]

14.  Secondary:   Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Streptococcus Pneumoniae (S. pn.) Cross-reactive Serotypes, in the Panama Subset.   [ Time Frame: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25 ]

15.  Secondary:   Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Other Pneumococcal Serotypes, in the Panama Subset.   [ Time Frame: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25 ]

16.  Secondary:   Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Haemophilus Influenzae (H. Influenzae), in the Panama Subset   [ Time Frame: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25 ]

17.  Secondary:   Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Non-typeable Haemophilus Influenzae (H. Influenzae), in the Panama Subset   [ Time Frame: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25 ]

18.  Secondary:   Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Other AOM Pathogens, in the Panama Subset   [ Time Frame: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25 ]

19.  Secondary:   Number of Subjects With a First Episode Reported of Community Acquired Pneumoniae (CAP) With Alveolar Consolidation or Pleural Effusion on the Chest X-ray (CXR) (C-CAP) With Positive Respiratory Viral Test (RVT)   [ Time Frame: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25 ]

20.  Secondary:   Number of Subjects With a First Episode Reported of Community Acquired Pneumoniae (CAP) With Any Abnormal CXR With Positive Respiratory Viral Test (RVT)   [ Time Frame: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25 ]

21.  Secondary:   Number of Subjects With a First Episode Reported of Bacterial Community Acquired Pneumoniae (B-CAP) With Positive Respiratory Viral Test (RVT).   [ Time Frame: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25 ]

22.  Secondary:   Number of Subjects With a First Episode Reported of Suspected Community Acquired Pneumoniae (CAP) (S-CAP)   [ Time Frame: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25 ]

23.  Secondary:   Number of Subjects With a First Episode Reported of Community Acquired Pneumoniae (CAP) With Any Abnormal Chest X-ray (CXR)   [ Time Frame: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25 ]

24.  Secondary:   Number of Subjects With a First Episode Reported of Suspected Community Acquired Pneumoniae (CAP) (S-CAP) With C Reactive Protein (CRP) >= Cut-off, Regardless of Chest X-ray (CXR) Reading   [ Time Frame: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25 ]

25.  Secondary:   Number of Subjects With a First Episode Reported of CAP With Either Alveolar Consolidation/Pleural Effusion on Chest X-ray (CXR) (C-CAP) or With Non-alveolar Infiltrates (NAI-CAP) But With C Reactive Protein (CRP) >= Cut-off.   [ Time Frame: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25 ]

26.  Secondary:   Number of Subjects With a First Episode Reported of Vaccine-type Invasive Pneumococcal Disease (VT-IPD).   [ Time Frame: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25 ]

27.  Secondary:   Number of Subjects With a First Episode Reported of a Bacteriologically Confirmed Invasive Pneumococcal Disease (Bact.-Conf. ID).   [ Time Frame: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25 ]

28.  Secondary:   Number of Subjects With a First Episode Reported of Pneumococcal Invasive Disease (Pneumococcal ID)   [ Time Frame: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25 ]

29.  Secondary:   Number of Subjects With a First Episode Reported of Invasive Pneumococcal Disease (IPD) Due to Streptococcus (S. pn.) Cross-reactive Pneumococcal Serotypes.   [ Time Frame: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25 ]

30.  Secondary:   Number of Subjects With a First Episode Reported of Invasive Pneumococcal Disease (IPD) Due to Pneumococcal Serotypes Other Than Streptococcus (S. pn.) Vaccine and Cross-reactive Serotypes.   [ Time Frame: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25 ]

31.  Secondary:   Number of Subjects With Streptococcus Pneumoniae (S. pn.) Vaccine Serotypes Identified in Nasopharyngeal Swabs, in the Carriage Subset.   [ Time Frame: At Months 5, 10-13, 13-16, 14-17, 16-19 and 22-25 ]

32.  Secondary:   Number of Subjects With Streptococcus Pneumoniae (S. pn.) Cross-reactive Serotypes Identified in Nasopharyngeal Swabs, in the Carriage Subset.   [ Time Frame: At Months 5, 10-13, 13-16, 14-17, 16-19 and 22-25 ]

33.  Secondary:   Number of Subjects With Streptococcus Pneumoniae (S. pn.) Serotypes Identified in Nasopharyngeal Swabs Other Than the Synflorix Vaccine and Cross-reactive Serotypes, in the Carriage Subset   [ Time Frame: At Months 5, 10-13, 13-16, 14-17, 16-19 and 22-25 ]

34.  Secondary:   Number of Subjects With H. Influenzae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset   [ Time Frame: At Months 5, 10-13, 13-16, 14-17, 16-19 and 22-25 ]

35.  Secondary:   Number of Subjects With Acquisition of New Streptococcus Pneumoniae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset   [ Time Frame: At Months 10-13, 13-16, 14-17, 16-19 and 22-25 ]

36.  Secondary:   Number of Subjects With Acquisition of New Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset.   [ Time Frame: At Months 10-13, 13-16, 14-17, 16-19 and 22-25 ]

37.  Secondary:   Number of Subjects With Any Antibiotic Prescription at Least Once During the Entire Study Period, in the Carriage Subset.   [ Time Frame: Throughout the study (Month 0 to Month 22-25) ]

38.  Secondary:   Pneumococcal Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset.   [ Time Frame: At Month 5, one month after the third dose of primary vaccination ]

39.  Secondary:   Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A, in the Immunogenicity and Tolerability Subset   [ Time Frame: At Month 5, one month after the third dose of primary vaccination ]

40.  Secondary:   Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset.   [ Time Frame: Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST) ]

41.  Secondary:   Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A, in the Immunogenicity and Tolerability Subset   [ Time Frame: Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST) ]

42.  Secondary:   Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset   [ Time Frame: At Month 5, one month after the third dose of primary vaccination ]

43.  Secondary:   Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset   [ Time Frame: At Month 5, one month after the third dose of primary vaccination ]

44.  Secondary:   Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset   [ Time Frame: Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST) ]

45.  Secondary:   Number of Subjects With Pneumococcal Antibody Concentrations Against Cross-reactive Serotypes 6A and 19A Higher >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset   [ Time Frame: Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST) ]

46.  Secondary:   Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset   [ Time Frame: At Month 5, one month after the third dose of primary vaccination ]

47.  Secondary:   Number of Subjects With Pneumococcal Antibody Concentrations Against Serotypes 6A and 19A >= 0.05 µg/mL, in the Immunogenicity and Tolerability Subset   [ Time Frame: At Month 5, one month after the third dose of primary vaccination ]

48.  Secondary:   Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset   [ Time Frame: Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST ]

49.  Secondary:   Number of Subjects With Pneumococcal Antibody Concentrations Against Serotypes 6A and 19A >= 0.05 µg/mL, in the Immunogenicity and Tolerability Subset   [ Time Frame: Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST) . ]

50.  Secondary:   Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset   [ Time Frame: At Month 5, one month after the third dose of primary vaccination, ]

51.  Secondary:   Titers for Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A, in the Immunogenicity and Tolerability Subset   [ Time Frame: At Month 5, one month after the third dose of primary vaccination ]

52.  Secondary:   Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset   [ Time Frame: Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST) ]

53.  Secondary:   Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 6A and 19A in the Immunogenicity and Tolerability Subset   [ Time Frame: Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST) ]

54.  Secondary:   Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F => 8, in the Immunogenicity and Tolerability Subset   [ Time Frame: At Month 5, one month after the third dose of primary vaccination ]

55.  Secondary:   Number of Subjects With Titers for Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A >= 8, in the Immunogenicity and Tolerability Subset   [ Time Frame: At Month 5, one month after the third dose of primary vaccination ]

56.  Secondary:   Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset   [ Time Frame: Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST) ]

57.  Secondary:   Number of Subjects With Titers for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A >= 8, in the Immunogenicity and Tolerability Subset   [ Time Frame: Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST). ]

58.  Secondary:   Concentrations of Antibodies Against Protein D (ANTI-PD), in the Immunogenicity and Tolerability Subset   [ Time Frame: At Month 5, one month after the third dose of primary vaccination ]

59.  Secondary:   Concentrations of Antibodies Against Protein D (ANTI-PD), in the Immunogenicity and Tolerability Subset   [ Time Frame: Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 Post-BST and M9 POST-BST) ]

60.  Secondary:   Number of Subjects With Anti-protein D (ANTI-PD) Antibody Concentrations >= 100 Enzyme-linked Immunosorbent Assay Units Per Milliliter ( EL.U/mL), in the Immunogenicity and Tolerability Subset   [ Time Frame: At Month 5, one month after the third dose of primary vaccination ]

61.  Secondary:   Number of Subjects With Anti-protein D (ANTI-PD) Antibody Concentrations >= 100 Enzyme-linked Immunosorbent Assay Units Per Milliliter ( EL.U/mL), in the Immunogenicity and Tolerability Subset.   [ Time Frame: Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 Post-BST and M9 POST-BST ]

62.  Secondary:   Number of Subjects With a First Episode Reported of Invasive Disease (ID) Due to Haemophilus Influenzae   [ Time Frame: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25 ]
Results not yet posted.   Anticipated Posting Date:   12/2050   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


Publications:
Sáez-Llorens X et al. Impact of 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) nasopharyngeal bacterial carriage in Panamanian children. Abstract presented at the 29th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID). 16-19 November 2011.
Tregnaghi M et al. Evaluating the efficacy of 10-valent pneumococcal non-typeable Haemophilus influenzae protein-D conjugate vaccine (PHiD-CV) against community-acquired pneumonia in Latin America. Abstract presented at the 29th annual meeting of the European Society for Paediatric Infectious Diseases (ESPID), The Hague, The Netherlands, 07-11 June, 2011.
Sáez-Llorens X et al. Design/setting of COMPAS: a Latin American trial evaluating the efficacy of 10-valent pneumococcal non-typeable Haemophilus influenzae protein-D conjugate vaccine (PHiD-CV). Abstract presented at the 29th annual meeting of the European Society for Paediatric Infectious Diseases (ESPID), The Hague, The Netherlands, 07-11 June, 2011.
Tregnaghi MW et al. Immunogenicity profile of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein-D conjugate vaccine (PHiD-CV) in Latin American children enrolled in COMPAS. Abstract presented at the 7th World Congress of the World Society for Pediatric Infectious Diseases (WSPID). Melbourne, Australia, 16-19 November 2011 (Abstract 430).
Sáez-Llorens X et al. Impact of 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) on nasopharyngeal bacterial carriage in Panamanian children. Abstract presented at the 7th World Congress of the World Society for Pediatric Infectious Diseases (WSPID). Melbourne, Australia, 16-19 November 2011 (Abstract 854).

Publications automatically indexed to this study:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00466947     History of Changes
Other Study ID Numbers: 109563
Study First Received: April 26, 2007
Results First Received: August 25, 2011
Last Updated: June 20, 2013
Health Authority: Colombia: INVIMA
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Panama: Instituto Conmemorativo Gorgas de Estudios de la Salud. Comité Nacional de Bioética de la Investigación