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Clinical Trial Results:
A Phase 1 Open-label Study to Assess the Safety and Tolerability of a Single Dose of 13-valent Pneumococcal Conjugate Vaccine in Healthy Chinese Adults, Children and Infants

Summary
EudraCT number	2014-004180-20
Trial protocol	Outside EU/EEA
Global end of trial date	06 Jan 2012

Results information
Results version number	v1(current)
This version publication date	29 Jun 2016
First version publication date	17 Jul 2015
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

B1851046

ISRCTN number

US NCT number

NCT01531322

WHO universal trial number (UTN)

Other trial identifiers

Alias: 6096A1-1000

Sponsor organisation name

Pfizer Inc.

Sponsor organisation address

235 E 42nd Street, New York, United States, NY 10017

Public contact

Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com

Scientific contact

Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Yes

Analysis stage

Final

Date of interim/final analysis

24 Jul 2012

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

06 Jan 2012

Was the trial ended prematurely?

Main objective of the trial

To assess the safety and tolerability of a single dose of 13-valent pneumococcal conjugate vaccine (13vPnC) as measured by the incidence of solicited local reactions, systemic events, and unsolicited adverse events (AEs) in healthy Chinese subjects in 3 age groups: Group 1: Adults aged 18 through 55 years, Group 2: Children aged 3 through 5 years, Group 3: Infants aged approximately 2 months.

Protection of trial subjects

The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.

Background therapy

Evidence for comparator

Actual start date of recruitment

19 Oct 2011

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

China: 72

Worldwide total number of subjects

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Screening details

The study was started on 19 Oct 2011 and completed on 06 Jan 2012 in China.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Not applicable

Blinding used

Not blinded

Are arms mutually exclusive

Yes

13vPnC Group 1

Arm description

Subjects aged 18 to 55 years received single 13vPnC dose on Day 1.

Arm type

Experimental

Investigational medicinal product name

13vPnC

Investigational medicinal product code

Other name

Prevenar 13

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Single 0.5 milliliter (mL) dose of 13vPnC administered intramuscularly on Day 1.

13vPnC Group 2

Arm description

Subjects aged 3 to 5 years received single 13vPnC dose on Day 1.

Arm type

Experimental

Investigational medicinal product name

13vPnC

Investigational medicinal product code

Other name

Prevenar 13

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Single 0.5 mL dose of 13vPnC administered intramuscularly on Day 1.

13vPnC Group 3

Arm description

Subjects aged 2 months (42 to 98 days) received single 13vPnC dose on Day 1.

Arm type

Experimental

Investigational medicinal product name

13vPnC

Investigational medicinal product code

Other name

Prevenar 13

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Single 0.5 mL dose of 13vPnC administered intramuscularly on Day 1.

Number of subjects in period 1	13vPnC Group 1	13vPnC Group 2	13vPnC Group 3
Started	24	24	24
Vaccinated	24	24	24
Completed	24	24	24

Baseline characteristics

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Reporting group title

13vPnC Group 1

Reporting group description

Subjects aged 18 to 55 years received single 13vPnC dose on Day 1.

Reporting group title

13vPnC Group 2

Reporting group description

Subjects aged 3 to 5 years received single 13vPnC dose on Day 1.

Reporting group title

13vPnC Group 3

Reporting group description

Subjects aged 2 months (42 to 98 days) received single 13vPnC dose on Day 1.

Reporting group values	13vPnC Group 1	13vPnC Group 2	13vPnC Group 3	Total
Number of subjects	24	24	24	72
Age categorical
Units: Subjects
18 years - 55 years	24	0	0	24
3 years - 5 years	0	24	0	24
42 days - 98 days	0	0	24	24
Gender categorical
Units: Subjects
Female	11	11	8	30
Male	13	13	16	42

End points

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Reporting group title

13vPnC Group 1

Reporting group description

Subjects aged 18 to 55 years received single 13vPnC dose on Day 1.

Reporting group title

13vPnC Group 2

Reporting group description

Subjects aged 3 to 5 years received single 13vPnC dose on Day 1.

Reporting group title

13vPnC Group 3

Reporting group description

Subjects aged 2 months (42 to 98 days) received single 13vPnC dose on Day 1.

Primary: Number of Subjects With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)

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End point title

Number of Subjects With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) ^[1]

End point description

An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to one month after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs. The safety analysis population included all subjects who received at least 1 dose of investigational product.

End point type

Primary

End point timeframe

Within 1 month after 13vPnC Dose

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Only descriptive data was planned to be reported for this endpoint.

End point values	13vPnC Group 1	13vPnC Group 2	13vPnC Group 3
Number of subjects analysed	24	24	24
Units: Subjects
AE	0	0	1
SAE	0	0	1

No statistical analyses for this end point

Primary: Percentage of Subjects Reporting Pre-Specified Local Reactions

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End point title

Percentage of Subjects Reporting Pre-Specified Local Reactions ^[2]

End point description

Local reactions reported by electronic diary(ediary).Redness,swelling scaled as:any(present); mild(13vPnC Group1: 2.5-5.0 centimeters[cm],13vPnC Group2,3: 0.5-2.0 cm);moderate(Group1:more than[>]5.0-10.0 cm,Group2,3:>2.0-7.0 cm)and severe(Group1:>10.0 cm, Group2,3:>7.0 cm)and necrosis or exfoliative dermatitis.Pain assessed only for Group1 as:any(any pain);mild(does not interfere with activity);moderate(interferes with activity);severe(prevents daily activity) and emergency room(ER)or Hospitalized(required ER visit or hospitalization).ER visit for 1 subject due to pain at injection site was reported in error.Tenderness was assessed for Group2,3 and scaled as:any(any grade of tenderness);present(tenderness present)and interferes with limb movement.Subjects may be represented in more than 1 category.Safety analysis population analyzed.Here"99999"for number and"+/-99999"for confidence interval signifies"not available"as data was not planned to be analyzed for that reporting arms

End point type

Primary

End point timeframe

Within 7 Days after 13vPnC Dose

Notes
[2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Only descriptive data was planned to be reported for this endpoint.

End point values	13vPnC Group 1	13vPnC Group 2	13vPnC Group 3
Number of subjects analysed	24	24	24
Units: Percentage of Subjects
number (confidence interval 95%)
Redness: Any	16.7 (4.7 to 37.4)	16.7 (4.7 to 37.4)	12.5 (2.7 to 32.4)
Redness: Mild	12.5 (2.7 to 32.4)	8.3 (1 to 27)	12.5 (2.7 to 32.4)
Redness: Moderate	12.5 (2.7 to 32.4)	8.3 (1 to 27)	0 (0 to 14.2)
Redness: Severe	0 (0 to 14.2)	0 (0 to 14.2)	0 (0 to 14.2)
Redness: Necrosis or exfoliative dermatitis	0 (0 to 14.2)	99999 (-99999 to 99999)	99999 (-99999 to 99999)
Swelling: Any	16.7 (4.7 to 37.4)	29.2 (12.6 to 51.1)	25 (9.8 to 46.7)
Swelling: Mild	12.5 (2.7 to 32.4)	20.8 (7.1 to 42.2)	16.7 (4.7 to 37.4)
Swelling: Moderate	12.5 (2.7 to 32.4)	20.8 (7.1 to 42.2)	8.3 (1 to 27)
Swelling: Severe	0 (0 to 14.2)	0 (0 to 14.2)	0 (0 to 14.2)
Swelling: Necrosis or exfoliative dermatitis	0 (0 to 14.2)	99999 (-99999 to 99999)	99999 (-99999 to 99999)
Pain at injection site: Any	95.8 (78.9 to 99.9)	99999 (-99999 to 99999)	99999 (-99999 to 99999)
Pain at injection site: Mild	95.8 (78.9 to 99.9)	99999 (-99999 to 99999)	99999 (-99999 to 99999)
Pain at injection site: Moderate	12.5 (2.7 to 32.4)	99999 (-99999 to 99999)	99999 (-99999 to 99999)
Pain at injection site: Severe	0 (0 to 14.2)	99999 (-99999 to 99999)	99999 (-99999 to 99999)
Pain at injection site: ER or Hospitalized	4.2 (0.1 to 21.1)	99999 (-99999 to 99999)	99999 (-99999 to 99999)
Tenderness: Any	99999 (-99999 to 99999)	75 (53.3 to 90.2)	12.5 (2.7 to 32.4)
Tenderness: Present	99999 (-99999 to 99999)	75 (53.3 to 90.2)	12.5 (2.7 to 32.4)
Tenderness: Interferes with limb movement	99999 (-99999 to 99999)	0 (0 to 14.2)	0 (0 to 14.2)

No statistical analyses for this end point

Primary: Percentage of Subjects Reporting Pre-Specified Systemic Events for 13vPnC Group 1

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End point title

Percentage of Subjects Reporting Pre-Specified Systemic Events for 13vPnC Group 1 ^[3] ^[4]

End point description

Systemic events involved any fever greater than or equal to (>=) 37.7 degrees Celsius (C) as per State Food and Drug Administration (SFDA) China or >=38.0 degrees C to >40.0 degrees C. Vomiting was scaled as= mild: 1 to 2 times in 24 hours (hrs), moderate: >2 times in 24 hrs, severe: required intravenous (IV) hydration, ER or hospitalized: required an ER visit or hospitalization. Diarrhea was scaled as= mild: 2 to 3 loose stools in 24 hrs, moderate: 4 to 5 loose stools in 24 hrs, severe: 6 or more loose stools in 24 hrs. Headache, fatigue, muscle pain and joint pain were scaled as= mild: does not interfere with activity; moderate: some interference with activity; severe: prevents daily routine activity. Use of antipyretic medication was collected using an e-diary. Antipyretic medications used by 2 subjects was reported in error. The safety analysis population included all subjects who received at least 1 dose of investigational product.

End point type

Primary

End point timeframe

Within 7 days after 13vPnC Dose

Notes
[3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Only descriptive data was planned to be reported for this endpoint.
[4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Percentage of subjects reporting prepecified systemic events has been presented as separate endpoint for 13vPnC Group 1 and 13vPnC Group 2/13vPnC Group 3.

End point values	13vPnC Group 1
Number of subjects analysed	24
Units: Percentage of Subjects
number (confidence interval 95%)
Fever: >= 38.0 degrees C	4.2 (0.1 to 21.1)
Fever: >=38.0 degrees C but <=38.4 degrees C	0 (0 to 14.2)
Fever: >38.4 degrees C but <=38.9 degrees C	4.2 (0.1 to 21.1)
Fever: >38.9 degrees C but <=40.0 degrees C	0 (0 to 14.2)
Fever: >40.0 degrees C	0 (0 to 14.2)
Fever-SFDA: >=37.7 degrees C	4.2 (0.1 to 21.1)
Fever-SFDA: >=37.7 degrees C but <=38.5 degrees	4.2 (0.1 to 21.1)
Fever-SFDA: >=38.6 degrees C but <=39.5 degrees	0 (0 to 14.2)
Fever-SFDA: >=39.6 degrees C but <=40.5 degrees C	0 (0 to 14.2)
Fever-SFDA: >40.0 degrees C	0 (0 to 14.2)
Vomiting: Any	0 (0 to 14.2)
Vomiting: Mild	0 (0 to 14.2)
Vomiting: Moderate	0 (0 to 14.2)
Vomiting: Severe	0 (0 to 14.2)
Vomiting: ER or hospitalized	0 (0 to 14.2)
Diarrhea: Any	0 (0 to 14.2)
Diarrhea: Mild	0 (0 to 14.2)
Diarrhea: Moderate	0 (0 to 14.2)
Diarrhea: Severe	0 (0 to 14.2)
Diarrhea: ER or hospitalized	0 (0 to 14.2)
Headache: Any	4.2 (0.1 to 21.1)
Headache: Mild	4.2 (0.1 to 21.1)
Headache: Moderate	0 (0 to 14.2)
Headache: Severe	0 (0 to 14.2)
Headache: ER or hospitalized	0 (0 to 14.2)
Fatigue: Any	12.5 (2.7 to 32.4)
Fatigue: Mild	12.5 (2.7 to 32.4)
Fatigue: Moderate	0 (0 to 14.2)
Fatigue: Severe	0 (0 to 14.2)
Fatigue: ER or hospitalized	0 (0 to 14.2)
Muscle pain: Any	20.8 (7.1 to 42.2)
Muscle pain: Mild	20.8 (7.1 to 42.2)
Muscle pain: Moderate	8.3 (1 to 27)
Muscle pain: Severe	0 (0 to 14.2)
Muscle pain: ER or hospitalized	0 (0 to 14.2)
Joint pain: Any	4.2 (0.1 to 21.1)
Joint pain: Mild	4.2 (0.1 to 21.1)
Joint pain: Moderate	0 (0 to 14.2)
Joint pain: Severe	0 (0 to 14.2)
Joint pain: ER or hospitalized	0 (0 to 14.2)
Use of antipyretic medications	8.3 (1 to 27)

No statistical analyses for this end point

Primary: Percentage of Subjects Reporting Pre-Specified Systemic Events for 13vPnC Group 2 and 13vPnC Group 3

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End point title

Percentage of Subjects Reporting Pre-Specified Systemic Events for 13vPnC Group 2 and 13vPnC Group 3 ^[5] ^[6]

End point description

Systemic events included: any fever >=38.0 degrees C, decreased appetite, irritability, increased sleep and decreased sleep. These were reported on each day. The use of antipyretic medication was reported in e-diary. The safety analysis population included all subjects who received at least 1 dose of investigational product.

End point type

Primary

End point timeframe

Within 7 days after 13vPnC Dose

Notes
[5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Only descriptive data was planned to be reported for this endpoint.
[6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Percentage of subjects reporting prepecified systemic events has been presented as separate endpoint for 13vPnC Group 1 and 13vPnC Group 2/13vPnC Group 3.

End point values	13vPnC Group 2	13vPnC Group 3
Number of subjects analysed	24	24
Units: Percentage of Subjects
number (confidence interval 95%)
Fever: >=38.0 degrees C	0 (0 to 14.2)	0 (0 to 14.2)
Fever: >=38.0 degrees C but <=39.0 degrees C	0 (0 to 14.2)	0 (0 to 14.2)
Fever: >39.0 degrees C but <=40.0 degrees C	0 (0 to 14.2)	0 (0 to 14.2)
Fever: >40.0 degrees C	0 (0 to 14.2)	0 (0 to 14.2)
Decreased appetite	0 (0 to 14.2)	0 (0 to 14.2)
Irritability	0 (0 to 14.2)	12.5 (2.7 to 32.4)
Increased sleep	4.2 (0.1 to 21.1)	12.5 (2.7 to 32.4)
Decreased sleep	0 (0 to 14.2)	16.7 (4.7 to 37.4)
Use of antipyretic medications	0 (0 to 14.2)	0 (0 to 14.2)

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Adverse events (AEs)/serious AEs (SAEs): Within 1 month after 13vPnC Dose. Pre-specified AEs (local reactions, systemic events): Within 7 days after 13vPnC Dose

Adverse event reporting additional description

SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in e-diary (local, systemic reactions; systematic assessment), events collected on case report form (non-systematic assessment).

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

13.1

Reporting group title

13vPnC Group 1

Reporting group description

Subjects aged 18 to 55 years received single 13vPnC dose on Day 1.

Reporting group title

13vPnC Group 3

Reporting group description

Subjects aged 2 months (42 to 98 days) received single 13vPnC dose on Day 1.

Reporting group title

13vPnC Group 2

Reporting group description

Subjects aged 3 to 5 years received single 13vPnC dose on Day 1.

Serious adverse events	13vPnC Group 1	13vPnC Group 3	13vPnC Group 2
Total subjects affected by serious adverse events
subjects affected / exposed	0 / 24 (0.00%)	1 / 24 (4.17%)	0 / 24 (0.00%)
number of deaths (all causes)	0	0	0
number of deaths resulting from adverse events	0	0	0
Infections and infestations
Bronchopneumonia
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 24 (0.00%)	1 / 24 (4.17%)	0 / 24 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 0%

Non-serious adverse events	13vPnC Group 1	13vPnC Group 3	13vPnC Group 2
Total subjects affected by non serious adverse events
subjects affected / exposed	23 / 24 (95.83%)	9 / 24 (37.50%)	18 / 24 (75.00%)
General disorders and administration site conditions
Fever: >=38.0 degrees C
Additional description: Subjects affected and occurrences for LRs and SEs is same as e-diaries could not distinguish 1 occurrence from another within a subject/vaccination. Dictionary version not captured, hence 0.0 is mentioned. This was not assessed for Group 2 and 3.
alternative dictionary used: Systemic Events 0.0
subjects affected / exposed	1 / 24 (4.17%)	0 / 24 (0.00%)	0 / 24 (0.00%)
occurrences all number	1	0	0
Fever: >38.4 degrees C but <=38.9 degrees C
Additional description: Subjects affected and occurrences for LRs and SEs is same as e-diaries could not distinguish 1 occurrence from another within a subject/vaccination. Dictionary version not captured, hence 0.0 is mentioned. This was not assessed for Group 2 and 3.
alternative dictionary used: Systemic Events 0.0
subjects affected / exposed	1 / 24 (4.17%)	0 / 24 (0.00%)	0 / 24 (0.00%)
occurrences all number	1	0	0
Fever Grades by SFDA: >=37.7 degrees C
Additional description: Subjects affected and occurrences for LRs and SEs is same as e-diaries could not distinguish 1 occurrence from another within a subject/vaccination. Dictionary version not captured, hence 0.0 is mentioned. This was not assessed for Group 2 and 3.
alternative dictionary used: Systemic Events 0.0
subjects affected / exposed	1 / 24 (4.17%)	0 / 24 (0.00%)	0 / 24 (0.00%)
occurrences all number	1	0	0
Fever Grades by SFDA: >=37.7 degrees C but <=38.5 degrees C
Additional description: Subjects affected and occurrences for LRs and SEs is same as e-diaries could not distinguish 1 occurrence from another within a subject/vaccination. Dictionary version not captured, hence 0.0 is mentioned. This was not assessed for Group 2 and 3.
alternative dictionary used: Systemic Events 0.0
subjects affected / exposed	1 / 24 (4.17%)	0 / 24 (0.00%)	0 / 24 (0.00%)
occurrences all number	1	0	0
Headache: Any
Additional description: Subjects affected and occurrences for LRs and SEs is same as e-diaries could not distinguish 1 occurrence from another within a subject/vaccination. Dictionary version not captured, hence 0.0 is mentioned. This was not assessed for Group 2 and 3.
alternative dictionary used: Systemic Events 0.0
subjects affected / exposed	1 / 24 (4.17%)	0 / 24 (0.00%)	0 / 24 (0.00%)
occurrences all number	1	0	0
Headache: Mild
Additional description: Subjects affected and occurrences for LRs and SEs is same as e-diaries could not distinguish 1 occurrence from another within a subject/vaccination. Dictionary version not captured, hence 0.0 is mentioned. This was not assessed for Group 2 and 3.
alternative dictionary used: Systemic Events 0.0
subjects affected / exposed	1 / 24 (4.17%)	0 / 24 (0.00%)	0 / 24 (0.00%)
occurrences all number	1	0	0
Fatigue: Any
Additional description: Subjects affected and occurrences for LRs and SEs is same as e-diaries could not distinguish 1 occurrence from another within a subject/vaccination. Dictionary version not captured, hence 0.0 is mentioned. This was not assessed for Group 2 and 3.
alternative dictionary used: Systemic Events 0.0
subjects affected / exposed	3 / 24 (12.50%)	0 / 24 (0.00%)	0 / 24 (0.00%)
occurrences all number	3	0	0
Fatigue: Mild
Additional description: Subjects affected and occurrences for LRs and SEs is same as e-diaries could not distinguish 1 occurrence from another within a subject/vaccination. Dictionary version not captured, hence 0.0 is mentioned. This was not assessed for Group 2 and 3.
alternative dictionary used: Systemic Events 0.0
subjects affected / exposed	3 / 24 (12.50%)	0 / 24 (0.00%)	0 / 24 (0.00%)
occurrences all number	3	0	0
Muscle pain: Any
Additional description: Subjects affected and occurrences for LRs and SEs is same as e-diaries could not distinguish 1 occurrence from another within a subject/vaccination. Dictionary version not captured, hence 0.0 is mentioned. This was not assessed for Group 2 and 3.
alternative dictionary used: Systemic Events 0.0
subjects affected / exposed	5 / 24 (20.83%)	0 / 24 (0.00%)	0 / 24 (0.00%)
occurrences all number	5	0	0
Muscle pain: Mild
Additional description: Subjects affected and occurrences for LRs and SEs is same as e-diaries could not distinguish 1 occurrence from another within a subject/vaccination. Dictionary version not captured, hence 0.0 is mentioned. This was not assessed for Group 2 and 3.
alternative dictionary used: Systemic Events 0.0
subjects affected / exposed	5 / 24 (20.83%)	0 / 24 (0.00%)	0 / 24 (0.00%)
occurrences all number	5	0	0
Muscle pain: Moderate
Additional description: Subjects affected and occurrences for LRs and SEs is same as e-diaries could not distinguish 1 occurrence from another within a subject/vaccination. Dictionary version not captured, hence 0.0 is mentioned. This was not assessed for Group 2 and 3.
alternative dictionary used: Systemic Events 0.0
subjects affected / exposed	2 / 24 (8.33%)	0 / 24 (0.00%)	0 / 24 (0.00%)
occurrences all number	2	0	0
Joint pain: Any
Additional description: Subjects affected and occurrences for LRs and SEs is same as e-diaries could not distinguish 1 occurrence from another within a subject/vaccination. Dictionary version not captured, hence 0.0 is mentioned. This was not assessed for Group 2 and 3.
alternative dictionary used: Systemic Events 0.0
subjects affected / exposed	1 / 24 (4.17%)	0 / 24 (0.00%)	0 / 24 (0.00%)
occurrences all number	1	0	0
Joint pain: Mild
Additional description: Subjects affected and occurrences for LRs and SEs is same as e-diaries could not distinguish 1 occurrence from another within a subject/vaccination. Dictionary version not captured, hence 0.0 is mentioned. This was not assessed for Group 2 and 3.
alternative dictionary used: Systemic Events 0.0
subjects affected / exposed	1 / 24 (4.17%)	0 / 24 (0.00%)	0 / 24 (0.00%)
occurrences all number	1	0	0
Irritability
Additional description: Subjects affected and occurrences for LRs and SEs is same as e-diaries could not distinguish 1 occurrence from another within a subject/vaccination. Dictionary version not captured, hence 0.0 is mentioned. This was not assessed for Group 1.
alternative dictionary used: Systemic Events 0.0
subjects affected / exposed	0 / 24 (0.00%)	3 / 24 (12.50%)	0 / 24 (0.00%)
occurrences all number	0	3	0
Increased sleep
Additional description: Subjects affected and occurrences for LRs and SEs is same as e-diaries could not distinguish 1 occurrence from another within a subject/vaccination. Dictionary version not captured, hence 0.0 is mentioned. This was not assessed for Group 1.
alternative dictionary used: Systemic Events 0.0
subjects affected / exposed	0 / 24 (0.00%)	3 / 24 (12.50%)	1 / 24 (4.17%)
occurrences all number	0	3	1
Decreased sleep
Additional description: Subjects affected and occurrences for LRs and SEs is same as e-diaries could not distinguish 1 occurrence from another within a subject/vaccination. Dictionary version not captured, hence 0.0 is mentioned. This was not assessed for Group 1.
alternative dictionary used: Systemic Events 0.0
subjects affected / exposed	0 / 24 (0.00%)	4 / 24 (16.67%)	0 / 24 (0.00%)
occurrences all number	0	4	0
Skin and subcutaneous tissue disorders
Redness: Any
Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
alternative dictionary used: Local Reactions 0.0
subjects affected / exposed	4 / 24 (16.67%)	3 / 24 (12.50%)	4 / 24 (16.67%)
occurrences all number	4	3	4
Redness: Mild
Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Local Reactions 0.0
subjects affected / exposed	3 / 24 (12.50%)	3 / 24 (12.50%)	2 / 24 (8.33%)
occurrences all number	3	3	2
Redness: Moderate
Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Local Reactions 0.0
subjects affected / exposed	2 / 24 (8.33%)	0 / 24 (0.00%)	2 / 24 (8.33%)
occurrences all number	3	0	2
Swelling: Any
Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Local Reactions 0.0
subjects affected / exposed	4 / 24 (16.67%)	6 / 24 (25.00%)	7 / 24 (29.17%)
occurrences all number	4	6	7
Swelling: Mild
Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Local Reactions 0.0
subjects affected / exposed	3 / 24 (12.50%)	4 / 24 (16.67%)	5 / 24 (20.83%)
occurrences all number	3	4	5
Pain at injection site: Any
Additional description: Subjects affected and occurrences for LRs and SEs is same as e-diaries could not distinguish 1 occurrence from another within a subject/vaccination. Dictionary version not captured, hence 0.0 is mentioned. This was not assessed for Group 2 and 3.
alternative dictionary used: Local Reactions 0.0
subjects affected / exposed	23 / 24 (95.83%)	0 / 24 (0.00%)	0 / 24 (0.00%)
occurrences all number	23	0	0
Pain at injection site: Mild
Additional description: Subjects affected and occurrences for LRs and SEs is same as e-diaries could not distinguish 1 occurrence from another within a subject/vaccination. Dictionary version not captured, hence 0.0 is mentioned. This was not assessed for Group 2 and 3.
alternative dictionary used: Local Reactions 0.0
subjects affected / exposed	23 / 24 (95.83%)	0 / 24 (0.00%)	0 / 24 (0.00%)
occurrences all number	23	0	0
Pain at injection site: Moderate
Additional description: Subjects affected and occurrences for LRs and SEs is same as e-diaries could not distinguish 1 occurrence from another within a subject/vaccination. Dictionary version not captured, hence 0.0 is mentioned. This was not assessed for Group 2 and 3.
alternative dictionary used: Local Reactions 0.0
subjects affected / exposed	3 / 24 (12.50%)	0 / 24 (0.00%)	0 / 24 (0.00%)
occurrences all number	3	0	0
Pain at injection site: ER or Hospitalized
Additional description: Subjects affected and occurrences for LRs and SEs is same as e-diaries could not distinguish 1 occurrence from another within a subject/vaccination. Dictionary version not captured, hence 0.0 is mentioned. This was not assessed for Group 2 and 3.
alternative dictionary used: Local Reactions 0.0
subjects affected / exposed	1 / 24 (4.17%)	0 / 24 (0.00%)	0 / 24 (0.00%)
occurrences all number	1	0	0
Tenderness: Any
Additional description: Subjects affected and occurrences for LRs and SEs is same as e-diaries could not distinguish 1 occurrence from another within a subject/vaccination. Dictionary version not captured, hence 0.0 is mentioned. This was not assessed for Group 1.
alternative dictionary used: Local Reactions 0.0
subjects affected / exposed	0 / 24 (0.00%)	3 / 24 (12.50%)	18 / 24 (75.00%)
occurrences all number	0	3	18
Tenderness: Present
Additional description: Subjects affected and occurrences for LRs and SEs is same as e-diaries could not distinguish 1 occurrence from another within a subject/vaccination. Dictionary version not captured, hence 0.0 is mentioned. This was not assessed for Group 1.
alternative dictionary used: Local Reactions 0.0
subjects affected / exposed	0 / 24 (0.00%)	3 / 24 (12.50%)	18 / 24 (75.00%)
occurrences all number	0	3	18
Swelling: Moderate
Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Local Reactions 0.0
subjects affected / exposed	3 / 24 (12.50%)	2 / 24 (8.33%)	5 / 24 (20.83%)
occurrences all number	3	2	5

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Were there any global substantial amendments to the protocol? Yes

10 May 2011

1. Increased the observation period following vaccination from 20 minutes to 30 minutes.

18 Oct 2011

1. Added a category in the pain assessment, wherein subjects of Group 1 were asked in the e-diary to report whether the pain at the injection site required an emergency room (ER) visit or hospitalization. 2. Corrected the safety reporting period upto 1 month after the vaccination.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical Trial Results:
A Phase 1 Open-label Study to Assess the Safety and Tolerability of a Single Dose of 13-valent Pneumococcal Conjugate Vaccine in Healthy Chinese Adults, Children and Infants

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Subject disposition

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Baseline characteristics

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Primary: Number of Subjects With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)

Primary: Number of Subjects With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)

Primary: Percentage of Subjects Reporting Pre-Specified Local Reactions

Primary: Percentage of Subjects Reporting Pre-Specified Local Reactions

Primary: Percentage of Subjects Reporting Pre-Specified Systemic Events for 13vPnC Group 1

Primary: Percentage of Subjects Reporting Pre-Specified Systemic Events for 13vPnC Group 1

Primary: Percentage of Subjects Reporting Pre-Specified Systemic Events for 13vPnC Group 2 and 13vPnC Group 3

Primary: Percentage of Subjects Reporting Pre-Specified Systemic Events for 13vPnC Group 2 and 13vPnC Group 3

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Clinical trials

Clinical Trial Results: A Phase 1 Open-label Study to Assess the Safety and Tolerability of a Single Dose of 13-valent Pneumococcal Conjugate Vaccine in Healthy Chinese Adults, Children and Infants

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Number of Subjects With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)

Primary: Number of Subjects With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)

Primary: Percentage of Subjects Reporting Pre-Specified Local Reactions

Primary: Percentage of Subjects Reporting Pre-Specified Local Reactions

Primary: Percentage of Subjects Reporting Pre-Specified Systemic Events for 13vPnC Group 1

Primary: Percentage of Subjects Reporting Pre-Specified Systemic Events for 13vPnC Group 1

Primary: Percentage of Subjects Reporting Pre-Specified Systemic Events for 13vPnC Group 2 and 13vPnC Group 3

Primary: Percentage of Subjects Reporting Pre-Specified Systemic Events for 13vPnC Group 2 and 13vPnC Group 3

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Phase 1 Open-label Study to Assess the Safety and Tolerability of a Single Dose of 13-valent Pneumococcal Conjugate Vaccine in Healthy Chinese Adults, Children and Infants