Immunization of Children Previously Primed With GSK Pneumococcal Vaccine GSK1024850A and of Unprimed Children in Nigeria - Study Results

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Prevention
Condition:	Pneumococcal Disease
Interventions:	Biological: Pneumococcal vaccine GSK1024850A Biological: InfanrixTM

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The duration of the study depends on the group allocation. The duration of the study per subject can vary from 1 month (Synflorix/Infanrix primed Group) to 3 months (Synflorix/Infanrix unprimed Group).

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Because of an issue with the informed consent of a child, the data of the child, who had a non-related to study medication serious adverse event, are not detailed in this analysis. Data were reanalyzed for the 104 subjects with data available.

Reporting Groups

Description

Synflorix/Infanrix Primed Group

Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.

Synflorix/Infanrix Unprimed Group

Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.

Participant Flow: Overall Study

	Synflorix/Infanrix Primed Group	Synflorix/Infanrix Unprimed Group
STARTED	68 ^[1]	36
COMPLETED	67 ^[2]	36 ^[3]
NOT COMPLETED	1	0
Adverse Event	1	0

[1]	Issues with the informed consent obtained from one child led to related data not used in this report
[2]	Number of subjects who completed the follow-up visit at Month 1.
[3]	Number of subjects who completed the follow-up visit at Month 3.

Baseline Characteristics

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Reporting Groups

	Description
Synflorix/Infanrix Primed Group	Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
Synflorix/Infanrix Unprimed Group	Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
Total	Total of all reporting groups

Baseline Measures

	Synflorix/Infanrix Primed Group	Synflorix/Infanrix Unprimed Group	Total
Number of Participants [units: participants]	68	36	104
Age [units: Months] Mean ± Standard Deviation	16.7 ± 1.00	16.4 ± 0.91	16.55 ± 0.955
Gender [units: Subjects]
Female	29	17	46
Male	39	19	58

Outcome Measures

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1. Primary:

Number of Subjects Reporting Grade 3 Symptoms (Solicited and Unsolicited). [ Time Frame: Within 31 days (Day 0 to Day 30) after administration of a booster dose of Synflorix vaccine in the Synflorix/Infanrix primed Group. ]

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2. Secondary:

Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. [ Time Frame: Prior to and one month after the booster immunisation for the Synflorix/Infanrix primed Group and prior to the first dose and one month after Dose 2 in the Synflorix/Infanrix unprimed Group ]

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3. Secondary:

Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes. [ Time Frame: Prior to and one month after the booster immunisation for the Synflorix/Infanrix primed Group and prior to the first dose and one month after Dose 2 in the Synflorix/Infanrix unprimed Group ]

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4. Secondary:

Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes. [ Time Frame: One month after the booster immunisation for the Synflorix/Infanrix primed Group and one month after Dose 2 in the Synflorix/Infanrix unprimed Group ]

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5. Secondary:

Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes. [ Time Frame: One month after the booster immunisation for the Synflorix/Infanrix primed Group and one month after Dose 2 in the Synflorix/Infanrix unprimed Group ]

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6. Secondary:

Concentration of Antibodies Against Protein D (PD). [ Time Frame: Prior to and one month after the booster immunisation for the Synflorix/Infanrix primed Group and prior to the first dose and one month after Dose 2 in the Synflorix/Infanrix unprimed Group ]

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7. Secondary:

Number of Subjects Reporting Any and Grade 3 Solicited Local AEs. [ Time Frame: Within 4 days (Days 0-3) after vaccination. ]

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8. Secondary:

Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs. [ Time Frame: Within 4 days (Days 0-3) after vaccination. ]

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9. Secondary:

Number of Subjects Reporting Unsolicited AEs. [ Time Frame: Within 31 days (Days 0-30) after vaccination ]

Show Outcome Measure 9

10. Secondary:

Number of Subjects Reporting Serious Adverse Events (SAEs). [ Time Frame: During the entire study period, from the vaccination visit at Day 0 up to the end of the follow-up visit at Month 1 for the Synflorix/Infanrix primed Group and up to Month 3 for the Synflorix/Infanrix unprimed Group. ]

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Serious Adverse Events

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Other Adverse Events

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Time Frame	Solicited AEs: Within 4 days (Days 0-3) after vaccination. Unsolicited AEs: Within 31 days (Days 0-30) after vaccination. SAEs: From Day 0 up to Month 1 for the Synflorix/Infanrix primed Group and up to Month 3 for the Synflorix/Infanrix unprimed Group.
Additional Description	Because of an issue discovered with the informed consent obtained for one child after the original statistical analysis. The data of the child, who also had an SAE that was not considered to be related to the study medication by the investigator, have been removed from the results tables.

Frequency Threshold

Threshold above which other adverse events are reported	5%

Reporting Groups

Description

Synflorix/Infanrix Primed Group

Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.

Synflorix/Infanrix Unprimed Group

Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.

Other Adverse Events

	Synflorix/Infanrix Primed Group	Synflorix/Infanrix Unprimed Group
Total, other (not including serious) adverse events
# participants affected / at risk	27/68	13/36
Eye disorders
Conjunctivitis ^*
# participants affected / at risk	3/68 (4.41%)	2/36 (5.56%)
Gastrointestinal disorders
Enteritis ^*
# participants affected / at risk	0/68 (0.00%)	2/36 (5.56%)
General disorders
Fever ^†
# participants affected / at risk	8/68 (11.76%)	3/36 (8.33%)
Pain ^†
# participants affected / at risk	27/68 (39.71%)	13/36 (36.11%)
Swelling ^†
# participants affected / at risk	4/68 (5.88%)	2/36 (5.56%)
Infections and infestations
Respiratory tract infection ^*
# participants affected / at risk	13/68 (19.12%)	7/36 (19.44%)
Malaria ^*
# participants affected / at risk	8/68 (11.76%)	10/36 (27.78%)
Furuncle ^*
# participants affected / at risk	4/68 (5.88%)	1/36 (2.78%)
Upper respiratory tract infection ^*
# participants affected / at risk	3/68 (4.41%)	2/36 (5.56%)

†	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
Data were reanalyzed because an issue was discovered with the informed consent obtained for one child after the original statistical analysis. The child’s parent requested GlaxoSmithKline not to use the data of their child.

Results Point of Contact:

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

No publications provided

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT01153893 History of Changes
Other Study ID Numbers:	113199
Study First Received:	June 29, 2010
Results First Received:	February 9, 2012
Last Updated:	September 27, 2012
Health Authority:	Nigeria: National Agency for Food and Drug Administration and Control