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The purpose of this study is to evaluate the safety and immunogenicity of the 13-valent pneumococcal conjugate vaccine (13vPnC) in healthy infants. This is the first study with this vaccine in infants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 13vPnC | Experimental |
| |
| 7vPnC | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) | Biological |
| ||
| 7-Valent Pneumococcal Conjugate Vaccine (7vPnC) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Reporting Pre-Specified Local Reactions | Local reaction events were collected using a paper worksheet. Tenderness was scaled as Any (tenderness present); Significant (Sig.) (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (Mod.)(2.5 to 7.0 cm); Severe (Sev.)(> 7.0 cm). Participants may be represented in more than 1 category. | Within 15 days after each dose |
| Percentage of Participants Reporting Pre-Specified Systemic Events | Systemic events (fever [Fv] ≥ 38 degrees Celsius [C] but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased (decr.) appetite, irritability, increased sleep, decreased sleep, use of medication (Med.)to prevent symptoms (sx), and use of medication to treat symptoms) were reported using a paper worksheet. Participants may be represented in more than 1 category. | Within 15 days after each dose |
| Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Percentage of participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/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. | one month after 3-dose infant series (at 7 months of age) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose | Percentages of participants achieving WHO predefined antibody threshold ≥0.35μg/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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York | New York | 10045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20435707 | Derived | Bryant KA, Block SL, Baker SA, Gruber WC, Scott DA; PCV13 Infant Study Group. Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine. Pediatrics. 2010 May;125(5):866-75. doi: 10.1542/peds.2009-1405. |
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Participants were enrolled into the study according to the inclusion/exclusion criteria without a screening period.
Participants were recruited in the United States from September 2004 to September 2005.
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| ID | Title | Description |
|---|---|---|
| FG000 | 13vPnC | Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose). |
| FG001 | 7vPnC | Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Infant Series |
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| After Infant Series |
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| Toddler Dose |
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| ID | Title | Description |
|---|---|---|
| BG000 | 13vPnC | Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Reporting Pre-Specified Local Reactions | Local reaction events were collected using a paper worksheet. Tenderness was scaled as Any (tenderness present); Significant (Sig.) (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (Mod.)(2.5 to 7.0 cm); Severe (Sev.)(> 7.0 cm). Participants may be represented in more than 1 category. | The safety population included all participants who received at least 1 dose of vaccine;(n)=number of participants with known values. | Posted | Mar 2010 | Number | percentage of participants | Within 15 days after each dose |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 13vPnC Infant Series | Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthma exacerbation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukocytosis | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D011008 | Pneumococcal Infections |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D000069443 | Heptavalent Pneumococcal Conjugate Vaccine |
| ID | Term |
|---|---|
| D022242 | Pneumococcal Vaccines |
| D022541 | Streptococcal Vaccines |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
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| Biological |
|
| One month after the toddler dose (at 13 to 16 months of age) |
| Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Antibody geometric mean concentration (GMC) as measured by enzyme-linked immunosorbent assay (ELISA) 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) are presented. GMC ratios (13vPnC/7vPnC) and corresponding 2-sided 95% CI were evaluated. | One month after 3-dose infant series (at 7 months of age) |
| Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Antibody geometric mean concentration (GMC) as measured by ELISA with their corresponding 95% CI immediately before and after the toddler dose 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) are presented. | Immediately before (12 to 15 months of age) and one month after the toddler dose (13 to 16 months of age) |
| Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series | Percentage of participants achieving predefined antibody threshold levels for Haemophilus Influenzae Type b (Hib) polyribosylribitol phosphate (PRP), Diphtheria Toxoid, Polio (Types 1, 2, and 3), Pertussis (filamentous hemagglutinin [FHA], Pertussis Toxoid, and Pertactin), Tetanus, and Hepatitis B with the corresponding 95% CI for each concomitant antigen are presented. | One month after the infant series (7 months of age) |
| Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the Infant Series | one month after the infant series (7 months of age) |
| Geometric Mean Antibody Concentration of Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series | GMCs of anti-hepatitis B surface antigen (HBsAg) using a Food and Drug Administration (FDA) approved in vitro diagnostic kit are presented. | one month after the infant series (7 months of age) |
| Geometric Mean Antibody Concentration Diphtheria Toxoid and Anti-Tetanus Toxoid in 13vPnC Group Relative to 7vPnC Group After the Infant Series | one month after the infant series (7 months of age) |
| Geometric Mean Antibody Concentration of Polio in 13vPnC Group Relative to 7vPnC Group After the Infant Series | one month after the infant series (7 months of age) |
| Geometric Mean Antibody Concentration of Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series | one month after the infant series (7 months of age) |
| Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Percentage of participants achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) 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. | one month after the infant series (7 months of age) |
| Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose | Percentage of participants achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) 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) were assessed. Results are reported for the serotypes with a determinate antibody titer. | One month after the toddler dose (13 to 16 months of age) |
| Geometric Mean Antibody Titer (OPA) in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose | Antibody functionality/geometric mean titer (GMT) as measured by opsonophagocytic activity assay (OPA) 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 assessed. Results are reported for the serotypes with a determinate antibody titer. | One month after the Toddler Dose (13 to 16 months of age) |
| Physician Decision |
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| Protocol Violation |
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| Lost Kaiser coverage |
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| Non-compliant |
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| Sponsor request |
|
| NOT COMPLETED |
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| NOT COMPLETED |
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|
| BG001 | 7vPnC | Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose). |
| BG002 | Total | Total of all reporting groups |
| weeks |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | 7vPnc Dose 1 | Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 2 months of age (infant series Dose 1). |
| OG002 | 13vPnC Dose 2 | Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 4 months of age (infant series Dose 2). |
| OG003 | 7vPnC Dose 2 | Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 4 months of age (infant series Dose 2). |
| OG004 | 13vPnC Dose 3 | Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 6 months of age (infant series Dose 3). |
| OG005 | 7vPnC Dose 3 | Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 6 months of age (infant series Dose 3). |
| OG006 | 13vPnC Toddler Dose | Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose). |
| OG007 | 7vPnC Toddler Dose | Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose). |
|
|
| Primary | Percentage of Participants Reporting Pre-Specified Systemic Events | Systemic events (fever [Fv] ≥ 38 degrees Celsius [C] but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased (decr.) appetite, irritability, increased sleep, decreased sleep, use of medication (Med.)to prevent symptoms (sx), and use of medication to treat symptoms) were reported using a paper worksheet. Participants may be represented in more than 1 category. | The safety population included all participants who received at least 1 dose of vaccine; (n)=number of participants with known values. | Posted | Mar 2010 | Number | percentage of participants | Within 15 days after each dose |
|
|
|
| Primary | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Percentage of participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/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. | Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n)=number of participants with a determinate postinfant series IgG antibody concentration to the given serotype. | Posted | Mar 2010 | Number | 95% Confidence Interval | percentage of participants | one month after 3-dose infant series (at 7 months of age) |
|
|
|
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| Secondary | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose | Percentages of participants achieving WHO predefined antibody threshold ≥0.35μg/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. | The All-Available Toddler Immunogenicity population consisted of eligible participants who had at least 1 valid and determinate assay result related to the proposed analysis; (n)=number of participants with a determinate posttoddler dose IgG antibody concentration to the given serotype. | Posted | Mar 2010 | Number | 95% Confidence Interval | percentage of participants | One month after the toddler dose (at 13 to 16 months of age) |
|
|
|
|
| Secondary | Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Antibody geometric mean concentration (GMC) as measured by enzyme-linked immunosorbent assay (ELISA) 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) are presented. GMC ratios (13vPnC/7vPnC) and corresponding 2-sided 95% CI were evaluated. | Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations;(n)=number of participants with a determinate antibody concentration for the specified serotype. | Posted | Mar 2010 | Geometric Mean | 95% Confidence Interval | μg/mL | One month after 3-dose infant series (at 7 months of age) |
|
|
|
|
| Secondary | Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose | Antibody geometric mean concentration (GMC) as measured by ELISA with their corresponding 95% CI immediately before and after the toddler dose 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) are presented. | All-Available Toddler Immunogenicity population consisted of eligible participants who had at least 1 valid and determinate assay result related to proposed analysis;(n)= number of participants with a determinate antibody concentration for the specified serotype. | Posted | Mar 2010 | Geometric Mean | 95% Confidence Interval | μg/mL | Immediately before (12 to 15 months of age) and one month after the toddler dose (13 to 16 months of age) |
|
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| Secondary | Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series | Percentage of participants achieving predefined antibody threshold levels for Haemophilus Influenzae Type b (Hib) polyribosylribitol phosphate (PRP), Diphtheria Toxoid, Polio (Types 1, 2, and 3), Pertussis (filamentous hemagglutinin [FHA], Pertussis Toxoid, and Pertactin), Tetanus, and Hepatitis B with the corresponding 95% CI for each concomitant antigen are presented. | Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations;(n)=number of participants with a determinate postinfant series antibody level to the given concomitant vaccine component. | Posted | Mar 2010 | Number | 95% Confidence Interval | Percentage of participants | One month after the infant series (7 months of age) |
|
|
|
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| Secondary | Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the Infant Series | Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N)= number of participants with a determinate antibody concentration for the specified concomitant vaccine component. | Posted | Mar 2010 | Geometric Mean | 95% Confidence Interval | μg/mL | one month after the infant series (7 months of age) |
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| Secondary | Geometric Mean Antibody Concentration of Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series | GMCs of anti-hepatitis B surface antigen (HBsAg) using a Food and Drug Administration (FDA) approved in vitro diagnostic kit are presented. | Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N)=number of participants with a determinate antibody concentration for the specified concomitant vaccine component. | Posted | Mar 2010 | Geometric Mean | 95% Confidence Interval | milli International Units (mIU)/mL | one month after the infant series (7 months of age) |
|
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| Secondary | Geometric Mean Antibody Concentration Diphtheria Toxoid and Anti-Tetanus Toxoid in 13vPnC Group Relative to 7vPnC Group After the Infant Series | Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N)=number of participants with a determinate antibody concentration for the specified concomitant vaccine component. | Posted | Mar 2010 | Geometric Mean | 95% Confidence Interval | IU/mL | one month after the infant series (7 months of age) |
|
|
|
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| Secondary | Geometric Mean Antibody Concentration of Polio in 13vPnC Group Relative to 7vPnC Group After the Infant Series | Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n)= number of participants with a postinfant series blood sample. | Posted | Mar 2010 | Geometric Mean | 95% Confidence Interval | titer | one month after the infant series (7 months of age) |
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| Secondary | Geometric Mean Antibody Concentration of Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series | Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N)= number of participants with a determinate antibody concentration for the specified concomitant vaccine component. | Posted | Mar 2010 | Geometric Mean | 95% Confidence Interval | EU/mL | one month after the infant series (7 months of age) |
|
|
|
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| Secondary | Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Percentage of participants achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) 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. | Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations;(n)=number of participants with a determinate postinfant series antibody titer to the given serotype. | Posted | Mar 2010 | Number | 95% Confidence Interval | Percentage of participants | one month after the infant series (7 months of age) |
|
|
|
| Secondary | Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose | Percentage of participants achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) 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) were assessed. Results are reported for the serotypes with a determinate antibody titer. | All-available (per protocol) population consisting of eligible participants who had at least 1 valid and determinate assay result related to the proposed analysis; (n)= number of participants with determinant posttoddler dose antibody titer to the given serotype. | Posted | Mar 2010 | Number | 95% Confidence Interval | Percentage of participants | One month after the toddler dose (13 to 16 months of age) |
|
|
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| Secondary | Geometric Mean Antibody Titer (OPA) in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose | Antibody functionality/geometric mean titer (GMT) as measured by opsonophagocytic activity assay (OPA) 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 assessed. Results are reported for the serotypes with a determinate antibody titer. | All-available (per protocol) population consisting of eligible participants who had at least 1 valid and determinate assay result related to the proposed analysis; (n)=number of participants with a determinant antibody titer for the specified serotype. | Posted | Mar 2010 | Geometric Mean | 95% Confidence Interval | titer | One month after the Toddler Dose (13 to 16 months of age) |
|
|
|
| 9 |
| 120 |
| 104 |
| 120 |
| EG001 | 7vPnC Infant Series | Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). | 9 | 126 | 110 | 126 |
| EG002 | 13vPnC Toddler Dose | Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose). | 1 | 86 | 33 | 86 |
| EG003 | 7vPnC Toddler Dose | Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose). | 0 | 103 | 51 | 103 |
| EG004 | 13vPnC 6-Month Follow-up | Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose). | 4 | 86 | 20 | 86 |
| EG005 | 7vPnC 6-Month Follow-up | Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose). | 1 | 103 | 33 | 103 |
| Bilateral otitis media | Infections and infestations | Non-systematic Assessment |
|
| Bronchiolitis | Infections and infestations | Non-systematic Assessment |
|
| Bronchiolitis RSV | Infections and infestations | Non-systematic Assessment |
|
| Chairi I malformation | Congenital, familial and genetic disorders | Non-systematic Assessment |
|
| Complex febrile seizure | Nervous system disorders | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Febrile illness (fever) | Infections and infestations | Non-systematic Assessment |
|
| Febrile seizure | Nervous system disorders | Non-systematic Assessment |
|
| Fever of unknown origin | Infections and infestations | Non-systematic Assessment |
|
| Gastroenteritis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Irritability | General disorders | Non-systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Lymphadenitis | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Otitis media | Infections and infestations | Non-systematic Assessment |
|
| Pneumococcal meningitis | Infections and infestations | Non-systematic Assessment |
|
| Pneumonia right middle lobe | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| RSV positive bronchiolitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Right upper and left lower lobe pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Rotaviral diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Seizure | Nervous system disorders | Non-systematic Assessment |
|
| Sensory integration disorder | Nervous system disorders | Non-systematic Assessment |
|
| Staphylococcal infection (hand) | Infections and infestations | Non-systematic Assessment |
|
| Status asthmaticus | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Tethered cord syndrome | Nervous system disorders | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
|
| Viral URI | Infections and infestations | Non-systematic Assessment |
|
| Viral conjunctivitis | Infections and infestations | Non-systematic Assessment |
|
| Viral respiratory infection | Infections and infestations | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Plagiocephaly | Congenital, familial and genetic disorders | Non-systematic Assessment |
|
| Dacryostenosis congenital | Congenital, familial and genetic disorders | Non-systematic Assessment |
|
| Ankyloglossia congenital | Congenital, familial and genetic disorders | Non-systematic Assessment |
|
| Macrocephaly | Congenital, familial and genetic disorders | Non-systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Cerumen impaction | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Conjunctivitis | Eye disorders | Non-systematic Assessment |
|
| Dacryostenosis acquired | Eye disorders | Non-systematic Assessment |
|
| Conjunctival haemorrhage | Eye disorders | Non-systematic Assessment |
|
| Eyelid ptosis | Eye disorders | Non-systematic Assessment |
|
| Strabismus | Eye disorders | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Umbilical hernia | Gastrointestinal disorders | Non-systematic Assessment |
|
| Teething | Gastrointestinal disorders | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | Non-systematic Assessment |
|
| Glossodynia | Gastrointestinal disorders | Non-systematic Assessment |
|
| Infantile spitting up | Gastrointestinal disorders | Non-systematic Assessment |
|
| Mouth cyst | Gastrointestinal disorders | Non-systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Pyrexia | General disorders | Non-systematic Assessment |
|
| Irritability | General disorders | Non-systematic Assessment |
|
| Granuloma | General disorders | Non-systematic Assessment |
|
| Xerosis | General disorders | Non-systematic Assessment |
|
| Allergy to chemicals | Immune system disorders | Non-systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | Non-systematic Assessment |
|
| Hypersensitivity | Immune system disorders | Non-systematic Assessment |
|
| Seasonal allergy | Immune system disorders | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
|
| Otitis media | Infections and infestations | Non-systematic Assessment |
|
| Bronchiolitis | Infections and infestations | Non-systematic Assessment |
|
| Otitis media acute | Infections and infestations | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | Non-systematic Assessment |
|
| Candida nappy rash | Infections and infestations | Non-systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | Non-systematic Assessment |
|
| Oral candidiasis | Infections and infestations | Non-systematic Assessment |
|
| Croup infectious | Infections and infestations | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | Non-systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | Non-systematic Assessment |
|
| Viral pharyngitis | Infections and infestations | Non-systematic Assessment |
|
| Candidiasis | Infections and infestations | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | Non-systematic Assessment |
|
| Viral rash | Infections and infestations | Non-systematic Assessment |
|
| Respiratory syncytial virus bronchiolitis | Infections and infestations | Non-systematic Assessment |
|
| Skin candida | Infections and infestations | Non-systematic Assessment |
|
| Acarodermatitis | Infections and infestations | Non-systematic Assessment |
|
| Body tinea | Infections and infestations | Non-systematic Assessment |
|
| Roseola | Infections and infestations | Non-systematic Assessment |
|
| Tinea infection | Infections and infestations | Non-systematic Assessment |
|
| Varicella | Infections and infestations | Non-systematic Assessment |
|
| Acute tonsillitis | Infections and infestations | Non-systematic Assessment |
|
| Dacryocystitis | Infections and infestations | Non-systematic Assessment |
|
| Eczema infected | Infections and infestations | Non-systematic Assessment |
|
| Erythema infectiosum | Infections and infestations | Non-systematic Assessment |
|
| Exanthema subitum | Infections and infestations | Non-systematic Assessment |
|
| Fungal skin infection | Infections and infestations | Non-systematic Assessment |
|
| Herpangina | Infections and infestations | Non-systematic Assessment |
|
| Infection | Infections and infestations | Non-systematic Assessment |
|
| Localised infection | Infections and infestations | Non-systematic Assessment |
|
| Nail infection | Infections and infestations | Non-systematic Assessment |
|
| Paronychia | Infections and infestations | Non-systematic Assessment |
|
| Pneumonia primary atypical | Infections and infestations | Non-systematic Assessment |
|
| Rash pustular | Infections and infestations | Non-systematic Assessment |
|
| Respiratory syncytial virus infection | Infections and infestations | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | Non-systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | Non-systematic Assessment |
|
| Tinea versicolour | Infections and infestations | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Traumatic brain injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Cardiac murmur | Investigations | Non-systematic Assessment |
|
| Cardiac murmur functional | Investigations | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Food intolerance | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Failure to thrive | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypervitaminosis a | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Lactose intolerance | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Torticollis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Haemangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Hypersomnia | Nervous system disorders | Non-systematic Assessment |
|
| Hypertonia | Nervous system disorders | Non-systematic Assessment |
|
| Hypotonia | Nervous system disorders | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | Non-systematic Assessment |
|
| Vesicoureteric reflux | Renal and urinary disorders | Non-systematic Assessment |
|
| Penile blister | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Vaginal discharge | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Tracheomalacia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Choking | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Macleod's syndrome | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Dermatitis diaper | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Rash macular | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Rash papular | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Erythema multiforme | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Heat rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Ingrowing nail | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Petechiae | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Rash erythematous | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Skin irritation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Corrective lens user | Social circumstances | Non-systematic Assessment |
|
| Exposure to communicable disease | Social circumstances | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Middle ear effusion | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Otorrhoea | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Scleral hyperaemia | Eye disorders | Non-systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | Non-systematic Assessment |
|
| Enteritis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Folliculitis | Infections and infestations | Non-systematic Assessment |
|
| Influenza | Infections and infestations | Non-systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | Non-systematic Assessment |
|
| Tinea capitis | Infections and infestations | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | Non-systematic Assessment |
|
| Arthropod sting | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Burns second degree | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Exposure to toxic agent | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Weight gain poor | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Speech disorder developmental | Nervous system disorders | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | Non-systematic Assessment |
|
| Penile adhesion | Renal and urinary disorders | Non-systematic Assessment |
|
| Acne infantile | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Keratosis pilaris | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Thalassaemia alpha | Congenital, familial and genetic disorders | Non-systematic Assessment |
|
| Food allergy | Immune system disorders | Non-systematic Assessment |
|
| Cellulitis orbital | Immune system disorders | Non-systematic Assessment |
|
| Conjunctivitis infective | Infections and infestations | Non-systematic Assessment |
|
| Oral herpes | Infections and infestations | Non-systematic Assessment |
|
| Rotavirus infection | Infections and infestations | Non-systematic Assessment |
|
| Back injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Weight bearing difficulty | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Febrile convulsion | Nervous system disorders | Non-systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Eye disorder | Eye disorders | Non-systematic Assessment |
|
| Tenderness (Any) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Infant Series Dose 1 and Toddler Dose; Tenderness (any)=present at site of vaccination. |
|
| Tenderness (Any) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Infant Series Dose 2; Tenderness (any) |
|
| Tenderness (Any) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Infant Series Dose 3; Tenderness (any) |
|
| Tenderness (Significant) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 1 and Toddler Dose; Tenderness (significant)=present and interfered with limb movement. |
|
| Tenderness (Significant) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 2; Tenderness (significant) |
|
| Tenderness (Significant) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 3; Tenderness (significant) |
|
| Induration (Any) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 1 and Toddler Dose; Induration (any)=present at site of vaccination. |
|
| Induration (Any) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 2; Induration (any) |
|
| Induration (Any) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 3; Induration (any) |
|
| Induration (Mild) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 1 and Toddler Dose; Induration (mild)=0.5 centimeters (cm) to 2.0 cm. |
|
| Induration (Mild) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 2; Induration (mild) |
|
| Induration (Mild) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 3; Induration (mild) |
|
| Induration (Moderate) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 1 and Toddler Dose; Induration (moderate)=2.5 cm to 7.0 cm. |
|
| Induration (Moderate) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 2; Induration (moderate) |
|
| Induration (Moderate) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 3; Induration (moderate) |
|
| Induration (Severe) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 1 and Toddler Dose; Induration (severe) >7.0 cm. |
|
| Induration (Severe) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 2; Induration (severe) |
|
| Induration (Severe) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 3; Induration (severe) |
|
| Erythema (Any) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 1 and Toddler Dose; Erythema (any)=present at site of vaccination. |
|
| Erythema (Any) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 2; Erythema (any) |
|
| Erythema (Any) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 3; Erythema (any) |
|
| Erythema (Mild) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 1 and Toddler Dose; Erythema (mild)=0.5 cm to 2.0 cm. |
|
| Erythema (Mild) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 2; Erythema (mild) |
|
| Erythema (Mild) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 3; Erythema (mild) |
|
| Erythema (Moderate) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 1 and Toddler Dose; Erythema (moderate)=2.5 cm to 7.0 cm. |
|
| Erythema (Moderate) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 2; Erythema (moderate) |
|
| Erythema (Moderate) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 3; Erythema (moderate) |
|
| Erythema (Severe) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 1 and Toddler Dose; Erythema (severe) >7.0 cm. |
|
| Erythema (Severe) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 2; Erythema (severe) |
|
| Erythema (Severe) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 3; Erythema (severe) |
|
| Fever ≥38°C but≤39°C | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 1 and Toddler Dose; Fever ≥38 degrees C but ≤39 degrees C |
|
| Fever ≥38°C but≤39°C | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 2; Fever ≥38 degrees C but ≤39 degrees C |
|
| Fever ≥38°C but≤39°C | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 3; Fever ≥38 degrees C but ≤39 degrees C |
|
| Fever >39°C but≤40°C | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 1 and Toddler Dose; Fever >39 degrees C but ≤40 degrees C |
|
| Fever >39°C but≤40°C | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 2; Fever >39 degrees C but ≤40 degrees C |
|
| Fever >39°C but≤40°C | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 3; Fever >39 degrees C but ≤40 degrees C |
|
| Fever >40°C | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 1 and Toddler Dose; Fever >40 degrees C |
|
| Fever >40°C | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 2; Fever >40 degrees C |
|
| Fever >40°C | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 3; Fever >40 degrees C |
|
| Decreased appetite | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 1 and Toddler Dose; Decreased appetite |
|
| Decreased appetite | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 2; Decreased appetite |
|
| Decreased appetite | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 3; Decreased appetite |
|
| Decreased sleep | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 1 and Toddler Dose; Irritability |
|
| Decreased sleep | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 2; Irritability |
|
| Decreased sleep | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 3; Irritability |
|
| Increased sleep | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 1 and Toddler Dose; Increased sleep |
|
| Increased sleep | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 2; Increased sleep |
|
| Increased sleep | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 3; Increased sleep |
|
| Irritability | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 1 and Toddler Dose; Irritability |
|
| Irritability | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 2; Irritability |
|
| Irritability | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 3; Irritability |
|
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.
| D007239 | Infections |
| D001688 |
| Biological Products |
| D045424 | Complex Mixtures |
| D017778 | Vaccines, Combined |
| Fv >39°C but≤40°C(n=113,121,102,113,101,113,77,94) |
|
| Fv >40°C (n=113,121,102,113,100,113,76,94) |
|
| Decr. Appetite (n=118,124,110,118,107,117,85,101) |
|
| Decr. Sleep (n=118,124,110,118,107,117,84,101) |
|
| Increased Sleep (n=119,124,111,118,107,117,86,101) |
|
| Irritability (n=118,124,110,118,107,117,85,101) |
|
| Med.-Prevent Sx (n=95,101,86,96,83,93,85,102) |
|
| Med.-Treat Symptoms (n=94,101,86,96,84,94,85,101) |
|
| Common Serotypes - Serotype 9V (n=94,108) |
|
| Common Serotypes - Serotype 14 (n=94,107) |
|
| Common Serotypes - Serotype 18C (n=94,106) |
|
| Common Serotypes - Serotype 19F (n=94,106) |
|
| Common Serotypes - Serotype 23F (n=94,108) |
|
| Additional Serotypes - Serotype 1 (n=94,108) |
|
| Additional Serotypes - Serotype 3 (n=94,107) |
|
| Additional Serotypes - Serotype 5 (n=93,107) |
|
| Additional Serotypes - Serotype 6A (n=93,106) |
|
| Additional Serotypes - Serotype 7F (n=94,105) |
|
| Additional Serotypes - Serotype 19A (n=94,107) |
|
| Difference |
| -0.49 |
| 2-Sided |
| 95 |
| -9.93 |
| 8.65 |
| No |
| Superiority or Other |
| For serotype 9V the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated | Difference | -2.27 | 2-Sided | 95 | -8.07 | 2.26 | No | Superiority or Other |
| For serotype 14 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated | Difference | 0.68 | 95 | -4.96 | 6.16 | No | Superiority or Other |
| For serotype 18C the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated | Difference | -2.25 | 95 | -8.18 | 2.36 | No | Superiority or Other |
| For serotype 19F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated | Difference | 0.70 | 95 | -4.84 | 6.32 | No | Superiority or Other |
| For serotype 23F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated | Difference | -0.69 | 95 | -7.75 | 5.86 | No | Superiority or Other |
| For serotype 1 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated | Difference | 72.87 | 95 | 63.32 | 81.07 | No | Superiority or Other |
| For serotype 3 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated | Difference | 84.92 | 95 | 76.73 | 91.05 | No | Superiority or Other |
| For serotype 5 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated | Difference | 57.94 | 95 | 48.01 | 67.42 | No | Superiority or Other |
| For serotype 6A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated | Difference | 62.81 | 95 | 52.33 | 72.20 | No | Superiority or Other |
| For serotype 7F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated | Difference | 92.27 | 95 | 85.26 | 96.54 | No | Superiority or Other |
| For serotype 19A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated | Difference | 5.61 | 95 | 1.23 | 11.86 | No | Superiority or Other |
| Common Serotypes - Serotype 9V (n=78,94) |
|
| Common Serotypes - Serotype 14 (n=78,93) |
|
| Common Serotypes - Serotype 18C (n=78,94) |
|
| Common Serotypes - Serotype 19F (n=78,93) |
|
| Common Serotypes - Serotype 23F (n=78,93) |
|
| Additional Serotypes - Serotype 1 (n=78,91) |
|
| Additional Serotypes - Serotype 3 (n=78,92) |
|
| Additional Serotypes - Serotype 5 (n=78,78) |
|
| Additional Serotypes - Serotype 6A (n=78,92) |
|
| Additional Serotypes - Serotype 7F (n=78,85) |
|
| Additional Serotypes - Serotype 19A (n=78,93) |
|
| Difference |
| 0.0 |
| 95 |
| -4.6 |
| 4.0 |
| No |
| Superiority or Other |
| For serotype 9V the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated | Difference | -1.3 | 95 | -6.9 | 2.8 | No | Superiority or Other |
| For serotype 14 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated | Difference | 0.0 | 95 | -4.6 | 4.0 | No | Superiority or Other |
| For serotype 18C the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated | Difference | 0.0 | 95 | -4.7 | 3.9 | No | Superiority or Other |
| For serotype 19F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated | Difference | 0.0 | 95 | -4.6 | 4.0 | No | Superiority or Other |
| For serotype 23F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated | Difference | 2.2 | 95 | -2.6 | 7.7 | No | Superiority or Other |
| For serotype 1 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated | Difference | 97.8 | 95 | 92.3 | 99.7 | No | Superiority or Other |
| For serotype 3 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated | Difference | 83.6 | 95 | 73.2 | 90.8 | No | Superiority or Other |
| For serotype 5 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated | Difference | 29.5 | 95 | 19.7 | 40.9 | No | Superiority or Other |
| For serotype 6A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated | Difference | 12.0 | 95 | 5.9 | 20.4 | No | Superiority or Other |
| For serotype 7F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated | Difference | 94.1 | 95 | 86.8 | 98.1 | No | Superiority or Other |
| For serotype 19A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated | Difference | 0.0 | 95 | -4.6 | 4.0 | No | Superiority or Other |
| Common Serotypes - Serotype 9V (n=94,108) |
|
| Common Serotypes - Serotype 14 (n=94,107) |
|
| Common Serotypes - Serotype 18C (n=94,106) |
|
| Common Serotypes - Serotype 19F (n=94,106) |
|
| Common Serotypes - Serotype 23F (n=94,108) |
|
| Additional Serotypes - Serotype 1 (n=94,108) |
|
| Additional Serotypes - Serotype 3 (n=94,107) |
|
| Additional Serotypes - Serotype 5 (n=93,107) |
|
| Additional Serotypes - Serotype 6A (n=93,106) |
|
| Additional Serotypes - Serotype 7F (n=94,105) |
|
| Additional Serotypes - Serotype 19A (n=94,107) |
|
| Ratio |
| 0.96 |
| 95 |
| 0.62 |
| 1.48 |
| No |
| Superiority or Other |
| For serotype 9V the GMC ratio (13vPnC/7vPnC) was calculated | Difference | 0.85 | 95 | 0.69 | 1.05 | No | Superiority or Other |
| For serotype 14 the GMC ratio (13vPnC/7vPnC) was calculated | Ratio | 0.82 | 95 | 0.60 | 1.11 | No | Superiority or Other |
| For serotype 18C the GMC ratio (13vPnC/7vPnC) was calculated | Ratio | 0.62 | 95 | 0.49 | 0.79 | No | Superiority or Other |
| For serotype 19F the GMC ratio (13vPnC/7vPnC) was calculated | Ratio | 0.86 | 95 | 0.67 | 1.09 | No | Superiority or Other |
| For serotype 23F the GMC ratio (13vPnC/7vPnC) was calculated | Ratio | 0.77 | 95 | 0.59 | 1.00 | No | Superiority or Other |
| For serotype 1 the GMC ratio (13vPnC/7vPnC) was calculated | Ratio | 39.78 | 95 | 27.47 | 57.63 | No | Superiority or Other |
| For serotype 3 the GMC ratio (13vPnC/7vPnC) was calculated | Ratio | 15.56 | 95 | 11.63 | 20.81 | No | Superiority or Other |
| For serotype 5 the GMC ratio (13vPnC/7vPnC) was calculated | Ratio | 8.67 | 95 | 6.65 | 11.29 | No | Superiority or Other |
| For serotype 6A the GMC ratio (13vPnC/7vPnC) was calculated | Ratio | 9.60 | 95 | 7.07 | 13.04 | No | Superiority or Other |
| For serotype 7F the GMC ratio (13vPnC/7vPnC) was calculated | Ratio | 26.78 | 95 | 20.97 | 34.22 | No | Superiority or Other |
| For serotype 19A the GMC ratio (13vPnC/7vPnC) was calculated | Ratio | 1.71 | 95 | 1.36 | 2.16 | No | Superiority or Other |
| Common Serotypes-Serotype 6B (n=82,98,78,93) |
|
| Common Serotypes-Serotype 9V (n=83,100,78,94) |
|
| Common Serotypes-Serotype 14 (n=83,100,78,93) |
|
| Common Serotypes-Serotype 18C (n=83,100,78,94) |
|
| Common Serotypes-Serotype 19F (n=82,100,78,93) |
|
| Common Serotypes-Serotype 23F (n=83,100,78,93) |
|
| Additional Serotypes-Serotype 1 (n=83,90,78,91) |
|
| Additional Serotypes-Serotype 3 (n=83,98,78,92) |
|
| Additional Serotypes-Serotype 5 (n=83,92,78,78) |
|
| Additional Serotypes-Serotype 6A (n=82,96,78,92) |
|
| Additional Serotypes-Serotype 7F (n=83,91,78,85) |
|
| Additional Serotypes-Serotype19A (n=83,100,78,93) |
|
| Diphtheria 0.01 IU/mL (n=38,48) |
|
| Diphtheria 0.1 IU/mL (n=38,48) |
|
| Tetanus 0.01 IU/mL (n=38,48) |
|
| Tetanus 0.1 IU/mL (n=38,48) |
|
| Polio Type 1 (antibody threshold ≥1:8) (n=61,64) |
|
| Polio Type 2 (antibody threshold ≥1:8) (n=61,64) |
|
| Polio Type 3 (antibody threshold ≥1:8) (n=61,63) |
|
| Hepatitis b 10 mIU/mL (n=38,48) |
|
| Pertussis - FHA 82.00 EU/MI (n=65,68) |
|
| Pertussis - Pertussis Toxoid 43.00 EU/mL (n=65,68) |
|
| Pertussis - Pertactin 18.00 EU/mL (n=65,68) |
|
| Difference |
| 7.02 |
| 95 |
| -7.28 |
| 21.14 |
| No |
| Superiority or Other |
| For Diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL and 0.1 IU/mL thresholds was calculated | Difference | 0.00 | 95 | -9.38 | 7.73 | No | Superiority or Other |
| For Tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL and 0.1 IU/mL thresholds was calculated | Difference | 0.00 | 95 | -9.38 | 7.73 | No | Superiority or Other |
| For Polio Type 1 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 threshold was calculated | Difference | 0.00 | 95 | -5.97 | 5.68 | No | Superiority or Other |
| For Polio Type 2 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 threshold was calculated | Difference | -1.64 | 95 | -8.80 | 4.24 | No | Superiority or Other |
| For Polio Type 3 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 threshold was calculated | Difference | -1.64 | 95 | -8.80 | 4.21 | No | Superiority or Other |
| For Hepatitis b the difference in percentage between the two groups (13vPnC - 7vPnC) at 10 mIU/mL threshold was calculated | Difference | 0.00 | 95 | -9.38 | 7.73 | No | Superiority or Other |
| For Pertussis - FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 82.00 EU/MI threshold was calculated | Difference | -1.74 | 95 | -11.00 | 6.99 | No | Superiority or Other |
| For Pertussis - PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 43.00 EU/mL threshold was calculated | Difference | -6.36 | 95 | -17.03 | 3.16 | No | Superiority or Other |
| For Pertussis - Pertactin the difference in percentage between the two groups (13vPnC - 7vPnC) at 18.00 EU/mL threshold was calculated | Difference | 1.33 | 95 | -6.79 | 9.68 | No | Superiority or Other |
| Polio Type 3 (n=61,63) |
|
| Ratio |
| 0.91 |
| 2-Sided |
| 95 |
| 0.56 |
| 1.49 |
| No |
| Superiority or Other |
| Polio Type 3 | Ratio | 1.12 | 2-Sided | 95 | 0.69 | 1.84 | No | Superiority or Other |
| Pertussis - pertactin |
|
| Ratio |
| 1.02 |
| 2-Sided |
| 95 |
| 0.83 |
| 1.25 |
| No |
| Superiority or Other |
| Pertussis - Pertactin | Ratio | 1.04 | 2-Sided | 95 | 0.76 | 1.44 | No | Superiority or Other |
| Common Serotypes - Serotype 9V (n=27,27) |
|
| Common Serotypes - Serotype 14 (n=27,30) |
|
| Common Serotypes - Serotype 18C (n=27,30) |
|
| Common Serotypes - Serotype 19F (n=25,25) |
|
| Common Serotypes - Serotype 23F (n=27,26) |
|
| Additional Serotypes - Serotype 1 (n=30,32) |
|
| Additional Serotypes - Serotype 3 (n=25,29) |
|
| Additional Serotypes - Serotype 5 (n=30,33) |
|
| Additional Serotypes - Serotype 6A (n=25,29) |
|
| Additional Serotypes - Serotype 7F (n=22,24) |
|
| Additional Serotypes - Serotype 19A (n=22,24) |
|