Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6-12wks of Age

This study has been completed.

Sponsor:

Information provided by:

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00808444

First received: December 11, 2008

Last updated: January 22, 2011

Last verified: January 2011

History of Changes

Results First Received: October 25, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Caregiver, Outcomes Assessor); Primary Purpose: Prevention
Conditions:	Pneumococcal Disease Streptococcus Pneumoniae Vaccines
Interventions:	Biological: Pneumococcal conjugate vaccine GSK1024850A (different lots) Biological: Infanrix hexa Biological: Infanrix-IPV/Hib Biological: Rotarix

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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

Description

Synflorix Clinical Lot & Infanrix Group

Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).

Synflorix Commercial Lot & Infanrix Group

Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).

Participant Flow: Overall Study

	Synflorix Clinical Lot & Infanrix Group	Synflorix Commercial Lot & Infanrix Group
STARTED	233	233
COMPLETED	232	232
NOT COMPLETED	1	1
Withdrawal by Subject	1	0
Lost to Follow-up	0	1

Baseline Characteristics

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Reporting Groups

	Description
Synflorix Clinical Lot & Infanrix Group	Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
Synflorix Commercial Lot & Infanrix Group	Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
Total	Total of all reporting groups

Baseline Measures

	Synflorix Clinical Lot & Infanrix Group	Synflorix Commercial Lot & Infanrix Group	Total
Number of Participants [units: participants]	233	233	466
Age [units: Weeks] Mean ± Standard Deviation	7.3 ± 1.35	7.2 ± 1.30	7.3 ± 1.32
Gender [units: Participants]
Female	113	104	217
Male	120	129	249

Outcome Measures

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1. Primary:

Concentrations of Antibodies Against Vaccine Components of the Pneumococcal Vaccine [ Time Frame: One month after primary immunization (month 4) ]

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2. Primary:

Concentration of Antibody Against Protein D (PD) [ Time Frame: One month after primary immunization (month 4) ]

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3. Secondary:

Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 µg/mL [ Time Frame: One month after primary immunization (month 4) ]

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4. Secondary:

Number of Subjects With Anti-pneumococcal Cross-reactive Serotype Concentrations Equal to or Above 0.20 µg/mL [ Time Frame: One month after primary immunization (month 4) ]

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5. Secondary:

Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes [ Time Frame: One month after primary immunization (month 4) ]

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6. Secondary:

Number of Subjects With Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes [ Time Frame: One month after primary immunization (month 4) ]

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7. Secondary:

Opsonophagocytic Titers of Cross-reactive Pneumococcal Serotypes [ Time Frame: One month after primary immunization (month 4) ]

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8. Secondary:

Poliovirus Types 1, 2 and 3 Titers [ Time Frame: One month after primary immunization (month 4) ]

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9. Secondary:

Concentrations of Antibodies Against Diphteria Toxoid (DT) and Tetanus Toxoid (TT) [ Time Frame: One month after primary immunization (month 4) ]

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10. Secondary:

Concentration of Antibody Against Hepatitis B Surface Antigen (HBs) [ Time Frame: One month after primary immunization (month 4) ]

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11. Secondary:

Concentration of Antibody Against Rotavirus Immunoglobulin A (IgA) [ Time Frame: 3 months after primary immunization (month 4) ]

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12. Secondary:

Occurrence of Serious Adverse Events [ Time Frame: Following vaccination and throughout the entire study period (Month 0 to Month 4) ]

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13. Secondary:

Opsonophagocytic Titers of Vaccine Pneumococcal Serotypes [ Time Frame: One month after primary immunization (month 4) ]

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Measure Type	Secondary
Measure Title	Opsonophagocytic Titers of Vaccine Pneumococcal Serotypes
Measure Description	Titers are presented as Geometric Mean Titers (GMTs). Pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Time Frame	One month after primary immunization (month 4)
Safety Issue	No

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.
Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.

Reporting Groups

Description

Synflorix Clinical Lot & Infanrix Group

Synflorix Commercial Lot & Infanrix Group

Measured Values

	Synflorix Clinical Lot & Infanrix Group	Synflorix Commercial Lot & Infanrix Group
Number of Participants Analyzed [units: participants]	209	210
Opsonophagocytic Titers of Vaccine Pneumococcal Serotypes [units: titer] Geometric Mean ( 95% Confidence Interval )
Opsono-1 (N=209;210)	128.9 ( 102.7 to 161.7 )	122.1 ( 98.3 to 151.7 )
Opsono-4 (N=207;207)	698.3 ( 619.6 to 786.9 )	609.3 ( 519.6 to 714.3 )
Opsono-5 (N=207;210)	127.9 ( 109.0 to 149.9 )	98.6 ( 83.0 to 117.1 )
Opsono-6B (N=205;206)	870.7 ( 710.2 to 1067.6 )	619.2 ( 483.4 to 793.2 )
Opsono-7F (N=206;208)	3905.8 ( 3420.2 to 4460.4 )	3585.7 ( 3119.8 to 4121.2 )
Opsono-9V (N=207;208)	1800.0 ( 1596.6 to 2029.3 )	1851.3 ( 1612.3 to 2125.8 )
Opsono-14 (N=209;208)	1521.0 ( 1313.3 to 1761.6 )	1485.8 ( 1280.5 to 1724.0 )
Opsono-18C (N=204;206)	533.5 ( 461.8 to 616.4 )	383.9 ( 319.3 to 461.5 )
Opsono-19F (N=206;206)	689.6 ( 581.1 to 818.2 )	573.5 ( 477.2 to 689.3 )
Opsono-23F (N=209;207)	2716.7 ( 2316.3 to 3186.3 )	2379.5 ( 2043.4 to 2770.7 )

No statistical analysis provided for Opsonophagocytic Titers of Vaccine Pneumococcal Serotypes

14. Secondary:

Number of Subjects With Solicited Local and General Symptoms. [ Time Frame: Within 4 days (day 0-3) after vaccination ]

Show Outcome Measure 14

15. Secondary:

Concentrations of Antibodies Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), Pertactin (PRN) [ Time Frame: One month after primary immunization (month 4) ]

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16. Secondary:

Concentration of Antibody Against Polyribosyl-ribitol Phosphate (PRP) [ Time Frame: One month after primary immunization (month 4) ]

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17. Secondary:

Occurrence of Unsolicited Adverse Events [ Time Frame: Within 31 days (day 0-30) after vaccination ]

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

Limitations and Caveats

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
No text entered.

Results Point of Contact:

Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343

No publications provided

Responsible Party:	E.D. Derilus; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00808444 History of Changes
Other Study ID Numbers:	111654
Study First Received:	December 11, 2008
Results First Received:	October 25, 2010
Last Updated:	January 22, 2011
Health Authority:	Malaysia: Ministry of Health Singapore: Health Sciences Authority

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