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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00489554

First received: June 20, 2007

Last updated: June 14, 2012

Last verified: June 2012

History of Changes

Results First Received: March 15, 2012

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Prevention
Condition:	Pneumococcal Disease
Interventions:	Biological: Synflorix Biological: Infanrix hexa 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
No text entered.

Reporting Groups

	Description
Synflorix Vaccine Group	Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.

Participant Flow: Overall Study

	Synflorix Vaccine Group
STARTED	230
COMPLETED	226
NOT COMPLETED	4
Adverse Event	2
Withdrawal by Subject	1
Lost to Follow-up	1

Baseline Characteristics

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Reporting Groups

	Description
Synflorix Vaccine Group	Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.

Baseline Measures

	Synflorix Vaccine Group
Number of Participants [units: participants]	230
Age [units: weeks] Mean ± Standard Deviation
weeks	8.2 ± 1.63
Gender [units: Participants]
Female	123
Male	107

Outcome Measures

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1. Primary:

Antibody Concentrations Against Pneumococcal Vaccine Serotypes [ Time Frame: One month after the administration of the 3rd vaccine dose i.e. Month 5 ]

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2. Primary:

Antibody Concentrations Against Protein D [ Time Frame: One month after the administration of the 3rd vaccine dose i.e. Month 5 ]

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3. Secondary:

Opsonophagocytic Titer Against Pneumococcal Vaccine Serotypes [ Time Frame: One month after the administration of the 3rd vaccine dose i.e. Month 5 ]

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4. Secondary:

Number of Subjects With Anti-pneumococcal Vaccine Serotypes Antibody Concentrations Greater Than or Equal to 0.2 Microgram Per Milliliter [ Time Frame: One month after the administration of the 3rd vaccine dose i.e. Month 5 ]

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5. Secondary:

Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes [ Time Frame: One month after the administration of the 3rd vaccine dose i.e. Month 5 ]

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6. Secondary:

Opsonophagocytic Titer Against Pneumococcal Cross-reactive Serotypes [ Time Frame: One month after the administration of the 3rd vaccine dose i.e. Month 5 ]

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7. Secondary:

Number of Subjects Seropositive Against Vaccine Pneumococcal Serotypes [ Time Frame: One month after the administration of the 3rd vaccine dose i.e. Month 5 ]

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8. Secondary:

Number of Subjects Seropositive for Opsonic Titer Against Vaccine Pneumococcal Serotypes [ Time Frame: One month after the administration of the 3rd vaccine dose i.e. Month 5 ]

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9. Secondary:

Number of Subjects Seropositive Against Cross-reactive Pneumococcal Serotypes [ Time Frame: One month after the administration of the 3rd vaccine dose i.e. Month 5 ]

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10. Secondary:

Number of Subjects Seropositive for Opsonic Titer Against Cross-reactive Pneumococcal Serotypes [ Time Frame: One month after the administration of the 3rd vaccine dose i.e. Month 5 ]

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11. Secondary:

Number of Subjects Seropositive for Anti-Protein D Antibodies [ Time Frame: One month after the administration of the 3rd vaccine dose i.e. Month 5 ]

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12. Secondary:

Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) [ Time Frame: Within 4 days following any vaccine dose ]

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13. Secondary:

Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs [ Time Frame: Within 4 days following any vaccine dose ]

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14. Secondary:

Number of Subjects Reporting Any Unsolicited AEs [ Time Frame: Within 31 days after any vaccine dose ]

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15. Secondary:

Number of Subjects Reporting Any Serious Adverse Events (SAEs) [ Time Frame: Up to Month 5 ]

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Serious Adverse Events

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Other Adverse Events

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Time Frame	Serious adverse events were assessed up to month 5. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 4 day and 31 day post vaccination period respectively.
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	5%

Reporting Groups

	Description
Synflorix Vaccine Group	Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.

Other Adverse Events

	Synflorix Vaccine Group
Total, other (not including serious) adverse events
# participants affected / at risk	198/230
General disorders
Pain ^†
# participants affected / at risk	196/230 (85.22%)
Redness ^†
# participants affected / at risk	91/230 (39.57%)
Swelling ^†
# participants affected / at risk	178/230 (77.39%)
Diarrhea ^†
# participants affected / at risk	55/230 (23.91%)
Drowsiness ^†
# participants affected / at risk	156/230 (67.83%)
Fever ^†
# participants affected / at risk	147/230 (63.91%)
Irritability ^†
# participants affected / at risk	198/230 (86.09%)
Loss of appetite ^†
# participants affected / at risk	113/230 (49.13%)
Vomiting ^†
# participants affected / at risk	56/230 (24.35%)
Nasopharyngitis ^*
# participants affected / at risk	123/230 (53.48%)
Pharyngitis ^*
# participants affected / at risk	37/230 (16.09%)
Conjunctivitis ^*
# participants affected / at risk	21/230 (9.13%)
Cough ^*
# participants affected / at risk	17/230 (7.39%)
Gastroenteritis ^*
# participants affected / at risk	16/230 (6.96%)
Diarrhea ^*
# participants affected / at risk	14/230 (6.09%)
Laryngitis ^*
# participants affected / at risk	13/230 (5.65%)

†	Events were collected by systematic assessment
*	Events were collected by non-systematic assessment

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

Publications:

Schuerman L et al. Population variability of opsonophagocytic activity following 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate (PHiD-CV) vaccination more limited than antibody responses. Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.

Schuerman L et al. Population variability in antibody responses following pneumococcal conjugate vaccination: experience with the non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.

Publications automatically indexed to this study:

Ruiz-Palacios GM, Guerrero ML, Hernández-Delgado L, Lavalle-Villalobos A, Casas-Muñoz A, Cervantes-Apolinar Y, Moreira M, Schuerman L. Immunogenicity, reactogenicity and safety of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Mexican infants. Hum Vaccin. 2011 Nov;7(11):1137-45. Epub 2011 Nov 1.

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00489554 History of Changes
Other Study ID Numbers:	109661
Study First Received:	June 20, 2007
Results First Received:	March 15, 2012
Last Updated:	June 14, 2012
Health Authority:	Mexico: Comisión de autorización Sanitaria - Dirección Ejecutiva de Autorización de Productos y Establecimientos

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