Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Children

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00824655
• Collaborator: (none)
• Enrollment: 234
• Locations: 7
• Arms: 2
• Duration (Months): 15
• Patients Per Site: 33.4
• Patients Per Site Per Month: 2.2

Study Details

Study Description

Brief Summary

The purposes of this study are to evaluate the safety of 13-valent pneumococcal Conjugate Vaccine (13vPnC) in children who have already been vaccinated with Prevenar. The study will also assess the immunological response (measure the amount of antibodies, i.e. proteins that fight off germs) produced by children after they have been given the 13-valent pneumococcal vaccine at 5 and 12 months or 12 months of age. In addition, reactions at the injection site will be assessed during the study.

Condition or Disease	Intervention/Treatment	Phase
Pneumococcal Vaccines	Biological: 13vPnC; Biological: 13vPnC	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 234 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: A Phase 3, Open-Label Trial, Evaluating the Safety, Tolerability, and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine in Healthy Children Previously Partially Immunized With Prevenar
• Study Start Date: Mar 1, 2009
• Actual Primary Completion Date: Jun 1, 2010
• Actual Study Completion Date: Jun 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1	Biological: 13vPnC; 13vPnC will be administered by intramuscular injection at approximately 5 and 12 months of age.
Experimental: Group 2	Biological: 13vPnC; 13vPnC will be administered by intramuscular injection at approximately 12 months of age.

Outcome Measures

Primary Outcome Measures

1. Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose [1 month after the toddler dose (13 months of age)]

   Antibody geometric mean concentration (GMC) as measured by micrograms per milliliter (mcg/mL) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. GMCs were calculated using all participants with available data for the specified blood draw.

Secondary Outcome Measures

1. Percentage of Participants Achieving a Serotype-specific IgG Antibody Greater Than or Equal To (≥) 0.35 Mcg/mL, 1 Month After the Infant Dose [1 Month after the infant series (6 months of age)]

   Percentage of participants achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.

2. GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured 1 Month After the Infant Dose [1 Month after the infant series (6 months of age)]

   Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. GMCs calculated using all participants with available data for the specified blood draw.

3. GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured Before the Toddler Dose [12 months of age (prior to toddler dose)]

   Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) presented. GMC (13vPnC) and corresponding 2-sided 95% CIs evaluated. GMCs calculated using all participants with available data for the specified blood draw.

Other Outcome Measures

1. Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (5 Months of Age) [Day 1 through Day 7 after vaccination]

   Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may have been represented in more than 1 category.

2. Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days of the Toddler Dose (12 Months of Age) [Day 1 through Day 7 after vaccination]

   Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may have been represented in more than 1 category.

3. Percentage of Participants Reporting Pre-specified Systemic Events Within 7 Days of the Infant Dose (5 Months of Age) [Day 1 through 7 after vaccination]

   Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may have been represented in more than 1 category.

4. Percentage of Participants Reporting Pre-specified Systemic Events Within 7 Days of the Toddler Dose (12 Months of Age) [Day 1 through 7 after vaccination]

   Systemic events (any fever ≥ 38 degrees C, decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may have been represented in more than 1 category.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 140 Days to 392 Days
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy children previously immunized with 1 or 2 doses of Prevenar.

• Group 1: Male or female subjects between the age of >=140 and <=196 days of age at time of enrollment.

• Group 2: Male or female subjects between the age of >=336 and <=392 days of age at time of enrollment

• Available for entire study period.

Exclusion Criteria:

• Previous reaction or contra-indication to pneumococcal vaccine or vaccine related component.

• Previous vaccination with licensed or investigational pneumococcal vaccine other than Prevenar.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Eskilstuna		Sweden	SE-63188
2	Pfizer Investigational Site	Goteborg		Sweden	SE-40014
3	Pfizer Investigational Site	Malmo		Sweden	SE-20502
4	Pfizer Investigational Site	Orebro		Sweden	SE-70185
5	Pfizer Investigational Site	Ostersund		Sweden	SE-83183
6	Pfizer Investigational Site	Uddevalla		Sweden	SE-45180
7	Pfizer Investigational Site	Umea		Sweden	SE-90185

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00824655
• Other Study ID Numbers: 6096A1-3012
• First Posted: Jan 19, 2009
• Last Update Posted: Aug 10, 2011
• Last Verified: Aug 1, 2011

• Keywords provided by , ,: Healthy Subjects; Vaccines; Pneumococcal

Study Results

Participant Flow

Pre-assignment Detail	Group 1 participants received 1 dose of Prevenar at least 42 days prior to study enrollment. Group 2 participants received 2 doses of Prevenar with the last dose at least 140 days prior to study enrollment.

Arm/Group Title	13vPnC/13vPnC	13vPnC
Arm/Group Description	Participants received two doses of 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7-valent pneumococcal conjugate vaccine (7vPnC), at approximately 3 months of age prior to enrollment in the study.	Participants received one dose of 13vPnC 0.5 mL IM at 12 months (Toddler dose) of age. Participants had received Prevenar, 7vPnC, at approximately 3 and 5 months of age prior to enrollment in the study.
Period Title: Infant Series (5 Months of Age)
STARTED	118	0
COMPLETED	118	0
NOT COMPLETED	0	0
Period Title: Infant Series (5 Months of Age)
STARTED	118	0
COMPLETED	118	0
NOT COMPLETED	0	0
Period Title: Infant Series (5 Months of Age)
STARTED	118	116
COMPLETED	116	116
NOT COMPLETED	2	0

Baseline Characteristics

Arm/Group Title	13vPnC/13vPnC	13vPnC	Total
Arm/Group Description	Participants received two doses of 13vPnC 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7vPnC, at approximately 3 months of age prior to enrollment in the study.	Participants received one dose of 13vPnC 0.5 mL IM at 12 months (Toddler dose) of age. Participants received Prevenar, 7vPnC, at approximately 3 and 5 months of age prior to enrollment in the study.	Total of all reporting groups
Overall Participants	118	116	234
Age (months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [months]	5.1 (0.37)	11.9 (0.52)	8.5 (3.42)
Sex/Gender, Customized (participants) [Number]
Female	50 42.4%	60 51.7%	110 47%
Male	68 57.6%	56 48.3%	124 53%

Outcome Measures

1. Primary Outcome

Title	Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose
Description	Antibody geometric mean concentration (GMC) as measured by micrograms per milliliter (mcg/mL) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. GMCs were calculated using all participants with available data for the specified blood draw.
Time Frame	1 month after the toddler dose (13 months of age)

Outcome Measure Data

Analysis Population Description

Evaluable Toddler Immunogenicity Population: eligible participants who received study vaccine at the expected dose(s), blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations.

Arm/Group Title	13vPnC/13vPnC	13vPnC
Arm/Group Description	Participants received two doses of 13vPnC 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7vPnC, at approximately 3 months of age prior to enrollment in the study.	Participants received one dose of 13vPnC 0.5 mL IM at 12 months (Toddler dose) of age. Participants received Prevenar, 7vPnC, at approximately 3 and 5 months of age prior to enrollment in the study.
Measure Participants	114	115
Common Serotype 4	5.27	5.06
Common Serotype 6B	9.63	8.75
Common Serotype 9V	3.50	3.33
Common Serotype 14	9.22	9.30
Common Serotype 18C	2.93	3.87
Common Serotype 19F	7.70	8.31
Common Serotype 23F	3.27	4.40
Additional Serotype 1	14.65	1.58
Additional Serotype 3	1.85	1.34
Additional Serotype 5	7.02	1.44
Additional Serotype 6A	6.14	2.48
Additional Serotype 7F	5.86	3.55
Additional Serotype 19A	7.25	13.16

2. Secondary Outcome

Title	Percentage of Participants Achieving a Serotype-specific IgG Antibody Greater Than or Equal To (≥) 0.35 Mcg/mL, 1 Month After the Infant Dose
Description	Percentage of participants achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.
Time Frame	1 Month after the infant series (6 months of age)

Outcome Measure Data

Analysis Population Description

Evaluable Infant Immunogenicity Population: eligible participants who received study vaccine at the expected dose(s), blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations.

Arm/Group Title	13vPnC/13vPnC
Arm/Group Description	Participants received two doses of 13vPnC 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7vPnC, at approximately 3 months of age prior to enrollment in the study.
Measure Participants	115
Common Serotype 4	99.1 84%
Common Serotype 6B	53.0 44.9%
Common Serotype 9V	99.1 84%
Common Serotype 14	96.5 81.8%
Common Serotype 18C	95.7 81.1%
Common Serotype 19F	92.2 78.1%
Common Serotype 23F	62.6 53.1%
Additional Serotype 1	80.9 68.6%
Additional Serotype 3	100.0 84.7%
Additional Serotype 5	83.5 70.8%
Additional Serotype 6A	36.8 31.2%
Additional Serotype 7F	93.0 78.8%
Additional Serotype 19A	87.8 74.4%

3. Secondary Outcome

Title	GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured 1 Month After the Infant Dose
Description	Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. GMCs calculated using all participants with available data for the specified blood draw.
Time Frame	1 Month after the infant series (6 months of age)

Outcome Measure Data

Analysis Population Description

Evaluable Infant Immunogenicity Population

Arm/Group Title	13vPnC/13vPnC
Arm/Group Description	Participants received two doses of 13vPnC 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7vPnC, at approximately 3 months of age prior to enrollment in the study.
Measure Participants	115
Common Serotype 4	2.90
Common Serotype 6B	0.40
Common Serotype 9V	1.73
Common Serotype 14	4.70
Common Serotype 18C	1.56
Common Serotype 19F	3.01
Common Serotype 23F	0.57
Additional Serotype 1	0.89
Additional Serotype 3	1.88
Additional Serotype 5	0.72
Additional Serotype 6A	0.28
Additional Serotype 7F	1.78
Additional Serotype 19A	0.85

4. Secondary Outcome

Title	GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured Before the Toddler Dose
Description	Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) presented. GMC (13vPnC) and corresponding 2-sided 95% CIs evaluated. GMCs calculated using all participants with available data for the specified blood draw.
Time Frame	12 months of age (prior to toddler dose)

Outcome Measure Data

Analysis Population Description

Evaluable Toddler Immunogenicity Population

Arm/Group Title	13vPnC/13vPnC	13vPnC
Arm/Group Description	Participants received two doses of 13vPnC 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7vPnC, at approximately 3 months of age prior to enrollment in the study.	Participants received one dose of 13vPnC 0.5 mL IM at 12 months (Toddler dose) of age. Participants received Prevenar, 7vPnC, at approximately 3 and 5 months of age prior to enrollment in the study.
Measure Participants	114	115
Common Serotype 4	0.66	0.62
Common Serotype 6B	0.83	0.65
Common Serotype 9V	0.74	0.70
Common Serotype 14	1.99	2.23
Common Serotype 18C	0.35	0.44
Common Serotype 19F	0.85	0.81
Common Serotype 23F	0.33	0.41
Additional Serotype 1	0.46	0.01
Additional Serotype 3	0.40	0.05
Additional Serotype 5	1.18	0.33
Additional Serotype 6A	0.71	0.24
Additional Serotype 7F	1.08	0.02
Additional Serotype 19A	1.06	1.55

5. Other Pre-specified Outcome

Title	Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (5 Months of Age)
Description	Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may have been represented in more than 1 category.
Time Frame	Day 1 through Day 7 after vaccination

Outcome Measure Data

Analysis Population Description

Safety Population: all participants who received at least 1 dose of the study vaccine; n = number of participants reporting yes for at least 1 day or no for all days for the specific characteristic

Arm/Group Title	13vPnC/13vPnC
Arm/Group Description	Participants received two doses of 13vPnC 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7vPnC, at approximately 3 months of age prior to enrollment in the study.
Measure Participants	113
Tenderness: Any (n=108)	36.1 30.6%
Tenderness: Significant (n=99)	3.0 2.5%
Swelling: Any (n=104)	33.7 28.6%
Swelling: Mild (n=104)	31.7 26.9%
Swelling: Moderate (n=101)	9.9 8.4%
Swelling: Severe (n=99)	0.0 0%
Redness: Any (n=107)	40.2 34.1%
Redness: Mild (n=107)	36.4 30.8%
Redness: Moderate (n=99)	4.0 3.4%
Redness: Severe (n=99)	0.0 0%

6. Other Pre-specified Outcome

Title	Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days of the Toddler Dose (12 Months of Age)
Description	Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may have been represented in more than 1 category.
Time Frame	Day 1 through Day 7 after vaccination

Outcome Measure Data

Analysis Population Description

Safety Population; n = number of participants reporting yes for at least 1 day or no for all days for the specific characteristic

Arm/Group Title	13vPnC/13vPnC	13vPnC
Arm/Group Description	Participants received two doses of 13vPnC 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7vPnC, at approximately 3 months of age prior to enrollment in the study.	Participants received one dose of 13vPnC 0.5 mL IM at 12 months (Toddler dose) of age. Participants received Prevenar, 7vPnC, at approximately 3 and 5 months of age prior to enrollment in the study.
Measure Participants	108	115
Tenderness: Any (n=104,110)	59.6 50.5%	52.7 45.4%
Tenderness: Significant (n=96,103)	5.2 4.4%	7.8 6.7%
Swelling: Any (n=104,110)	53.8 45.6%	54.5 47%
Swelling: Mild (n=104,109)	50.0 42.4%	52.3 45.1%
Swelling: Moderate (n=100,105)	24.0 20.3%	29.5 25.4%
Swelling: Severe (n=95,101)	0.0 0%	0.0 0%
Redness: Any (n=104,113)	62.5 53%	59.3 51.1%
Redness: Mild (n=103,113)	52.4 44.4%	51.3 44.2%
Redness: Moderate (n=98,106)	20.4 17.3%	26.4 22.8%
Redness: Severe (n=95,101)	0.0 0%	0.0 0%

7. Other Pre-specified Outcome

Title	Percentage of Participants Reporting Pre-specified Systemic Events Within 7 Days of the Infant Dose (5 Months of Age)
Description	Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may have been represented in more than 1 category.
Time Frame	Day 1 through 7 after vaccination

Outcome Measure Data

Analysis Population Description

Safety Population; n = number of participants reporting yes for at least 1 day or no for all days for the specific characteristic

Arm/Group Title	13vPnC/13vPnC
Arm/Group Description	Participants received two doses of 13vPnC 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7vPnC, at approximately 3 months of age prior to enrollment in the study.
Measure Participants	117
Fever ≥38 degrees C but ≤39 degrees C (n=103)	26.2 22.2%
Fever >39 degrees C but ≤40 degrees C (n=99)	2.0 1.7%
Fever >40 degrees C (n=99)	0.0 0%
Decreased appetite (n=107)	36.4 30.8%
Irritability (n=114)	80.7 68.4%
Increased sleep (n=106)	50.9 43.1%
Decreased sleep (n=112)	39.3 33.3%

8. Other Pre-specified Outcome

Title	Percentage of Participants Reporting Pre-specified Systemic Events Within 7 Days of the Toddler Dose (12 Months of Age)
Description	Systemic events (any fever ≥ 38 degrees C, decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may have been represented in more than 1 category.
Time Frame	Day 1 through 7 after vaccination

Outcome Measure Data

Analysis Population Description

Safety Population; n = number of participants reporting yes for at least 1 day or no for all days for the specific characteristic

Arm/Group Title	13vPnC/13vPnC	13vPnC
Arm/Group Description	Participants received two doses of 13vPnC 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7vPnC, at approximately 3 months of age prior to enrollment in the study.	Participants received one dose of 13vPnC 0.5 mL IM at 12 months (Toddler dose) of age. Participants received Prevenar, 7vPnC, at approximately 3 and 5 months of age prior to enrollment in the study.
Measure Participants	113	114
Fever ≥38 degrees C but ≤39 degrees C (n=99,105)	31.3 26.5%	32.4 27.9%
Fever >39 degrees C but ≤40 degrees C (n=96,102)	5.2 4.4%	3.9 3.4%
Fever >40 degrees C (n=95,101)	0.0 0%	0.0 0%
Decreased appetite (n=103,109)	46.6 39.5%	44.0 37.9%
Irritability (n=111,113)	82.0 69.5%	76.1 65.6%
Increased sleep (n=101,108)	49.5 41.9%	38.9 33.5%
Decreased sleep (n=105,106)	36.2 30.7%	33.0 28.4%

Adverse Events

Adverse Event Reporting Description	The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Arm/Group Title	13vPnC/13vPnC at 5 Months		13vPnC/13vPnC at 6 Months of Age		13vPnC/13vPnC at 12 Months		13vPnC at 12 Months
Arm/Group Description	13vPnC 0.5 mL dose administered IM at 5 months of age (infant dose)		13vPnC 0.5 mL dose administered IM at 5 months of age (infant dose); assessment 1 month after the infant series (6 months of age).		13vPnC 0.5 mL dose administered IM at 5 months (infant dose) and 12 months of age (toddler dose).		13vPnC 0.5 mL dose administered IM at 12 months of age (toddler dose).
All Cause Mortality
	13vPnC/13vPnC at 5 Months		13vPnC/13vPnC at 6 Months of Age		13vPnC/13vPnC at 12 Months		13vPnC at 12 Months
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	13vPnC/13vPnC at 5 Months		13vPnC/13vPnC at 6 Months of Age		13vPnC/13vPnC at 12 Months		13vPnC at 12 Months
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/118 (0.8%)		4/118 (3.4%)		1/116 (0.9%)		0/116 (0%)
Gastrointestinal disorders
Diarrhoea	1/118 (0.8%)		0/118 (0%)		1/116 (0.9%)		0/116 (0%)
Intussusception	0/118 (0%)		1/118 (0.8%)		0/116 (0%)		0/116 (0%)
Vomiting	0/118 (0%)		0/118 (0%)		1/116 (0.9%)		0/116 (0%)
Infections and infestations
Gastroenteritis	0/118 (0%)		4/118 (3.4%)		0/116 (0%)		0/116 (0%)
Bronchitis	0/118 (0%)		0/118 (0%)		1/116 (0.9%)		0/116 (0%)
Injury, poisoning and procedural complications
Foreign body	0/118 (0%)		1/118 (0.8%)		0/116 (0%)		0/116 (0%)
Respiratory, thoracic and mediastinal disorders
Asthma	0/118 (0%)		0/118 (0%)		1/116 (0.9%)		0/116 (0%)
Other (Not Including Serious) Adverse Events
	13vPnC/13vPnC at 5 Months		13vPnC/13vPnC at 6 Months of Age		13vPnC/13vPnC at 12 Months		13vPnC at 12 Months
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	92/118 (78%)		4/118 (3.4%)		91/116 (78.4%)		86/116 (74.1%)
Gastrointestinal disorders
Diarrhoea	1/118 (0.8%)		1/118 (0.8%)		2/116 (1.7%)		0/116 (0%)
Vomiting	1/118 (0.8%)		0/118 (0%)		5/116 (4.3%)		0/116 (0%)
Gastrooesophageal reflux disease	0/118 (0%)		1/118 (0.8%)		0/116 (0%)		0/116 (0%)
Teething	0/118 (0%)		0/118 (0%)		0/116 (0%)		1/116 (0.9%)
General disorders
Pyrexia	1/118 (0.8%)		0/118 (0%)		4/116 (3.4%)		4/116 (3.4%)
Injection site swelling	0/118 (0%)		0/118 (0%)		1/116 (0.9%)		0/116 (0%)
Irritability	0/118 (0%)		0/118 (0%)		0/116 (0%)		1/116 (0.9%)
Fever ≥38°C but ≤39°C	27/103 (26.2%)		0/0 (NaN)		31/99 (31.3%)		34/105 (32.4%)
Fever >39°C but ≤40°C	2/99 (2%)		0/0 (NaN)		5/96 (5.2%)		4/102 (3.9%)
Fever >40°C	0/99 (0%)		0/0 (NaN)		0/95 (0%)		0/101 (0%)
Decreased appetite	39/107 (36.4%)		0/0 (NaN)		48/103 (46.6%)		48/109 (44%)
Irritability	92/114 (80.7%)		0/0 (NaN)		91/111 (82%)		86/113 (76.1%)
Increased sleep	54/106 (50.9%)		0/0 (NaN)		50/101 (49.5%)		42/108 (38.9%)
Decreased sleep	44/112 (39.3%)		0/0 (NaN)		38/105 (36.2%)		35/106 (33%)
Infections and infestations
Nasopharyngitis	5/118 (4.2%)		0/118 (0%)		8/116 (6.9%)		7/116 (6%)
Exanthema subitum	1/118 (0.8%)		0/118 (0%)		0/116 (0%)		2/116 (1.7%)
Gastroenteritis	1/118 (0.8%)		0/118 (0%)		3/116 (2.6%)		0/116 (0%)
Pharyngitis streptococcal	1/118 (0.8%)		0/118 (0%)		0/116 (0%)		0/116 (0%)
Mastitis	0/118 (0%)		1/118 (0.8%)		0/116 (0%)		0/116 (0%)
Respiratory tract infection	0/118 (0%)		1/118 (0.8%)		0/116 (0%)		0/116 (0%)
Ear infection	0/118 (0%)		0/118 (0%)		2/116 (1.7%)		3/116 (2.6%)
Otitis media	0/118 (0%)		0/118 (0%)		2/116 (1.7%)		2/116 (1.7%)
Varicella	0/118 (0%)		0/118 (0%)		2/116 (1.7%)		1/116 (0.9%)
Upper respiratory tract infection	0/118 (0%)		0/118 (0%)		2/116 (1.7%)		0/116 (0%)
Bronchitis	0/118 (0%)		0/118 (0%)		0/116 (0%)		1/116 (0.9%)
Croup infectious	0/118 (0%)		0/118 (0%)		0/116 (0%)		1/116 (0.9%)
Cystitis	0/118 (0%)		0/118 (0%)		0/116 (0%)		1/116 (0.9%)
Viral infection	0/118 (0%)		0/118 (0%)		0/116 (0%)		1/116 (0.9%)
Injury, poisoning and procedural complications
Fall	0/118 (0%)		0/118 (0%)		0/116 (0%)		2/116 (1.7%)
Foreign body	0/118 (0%)		0/118 (0%)		0/116 (0%)		1/116 (0.9%)
Skin laceration	0/118 (0%)		0/118 (0%)		0/116 (0%)		1/116 (0.9%)
Thermal burn	0/118 (0%)		0/118 (0%)		0/116 (0%)		1/116 (0.9%)
Musculoskeletal and connective tissue disorders
Lower extremity mass	0/118 (0%)		0/118 (0%)		1/116 (0.9%)		0/116 (0%)
Nervous system disorders
Crying	1/118 (0.8%)		0/118 (0%)		0/116 (0%)		0/116 (0%)
Respiratory, thoracic and mediastinal disorders
Cough	1/118 (0.8%)		0/118 (0%)		1/116 (0.9%)		0/116 (0%)
Obstructive airways disorder	0/118 (0%)		0/118 (0%)		0/116 (0%)		1/116 (0.9%)
Skin and subcutaneous tissue disorders
Eczema	1/118 (0.8%)		0/118 (0%)		0/116 (0%)		0/116 (0%)
Rash macular	1/118 (0.8%)		1/118 (0.8%)		0/116 (0%)		0/116 (0%)
Rash	0/118 (0%)		0/118 (0%)		2/116 (1.7%)		1/116 (0.9%)
Erythema	0/118 (0%)		0/118 (0%)		1/116 (0.9%)		0/116 (0%)
Urticaria	0/118 (0%)		0/118 (0%)		0/116 (0%)		1/116 (0.9%)
Tenderness (Any)	39/108 (36.1%)		0/0 (NaN)		62/104 (59.6%)		58/110 (52.7%)
Tenderness (Significant)	3/99 (3%)		0/0 (NaN)		5/96 (5.2%)		8/103 (7.8%)
Swelling (Any)	35/104 (33.7%)		0/0 (NaN)		56/104 (53.8%)		60/110 (54.5%)
Swelling (Mild)	33/104 (31.7%)		0/0 (NaN)		52/104 (50%)		57/109 (52.3%)
Swelling (Moderate)	10/101 (9.9%)		0/0 (NaN)		24/100 (24%)		31/105 (29.5%)
Swelling (Severe)	0/99 (0%)		0/0 (NaN)		0/95 (0%)		0/101 (0%)
Redness (Any)	43/107 (40.2%)		0/0 (NaN)		65/104 (62.5%)		67/113 (59.3%)
Redness (Mild)	39/107 (36.4%)		0/0 (NaN)		54/103 (52.4%)		58/113 (51.3%)
Redness (Moderate)	4/99 (4%)		0/0 (NaN)		20/98 (20.4%)		28/106 (26.4%)
Redness (Severe)	0/99 (0%)		0/0 (NaN)		0/95 (0%)		0/101 (0%)

Limitations/Caveats

[Not Specified]

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Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.