Vaccines, PneumococcalPhase 3NCT00366899

Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Infants

A Phase 3 study testing 13-valent pneumococcal conjugate vaccine and 7 valent pneumococcal conjugate vaccine in people with Vaccines, Pneumococcal, run by Wyeth is now a wholly owned subsidiary of Pfizer at 13 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given concomitantly with routine paediatric vaccinations in Italy. Read more about this study

Who is it for?: Ages 75 to 105 daysHealthy volunteers can take part
Conditions the study is for: Vaccines, Pneumococcal
What is being tested?: 13-valent pneumococcal conjugate vaccine and 7 valent pneumococcal conjugate vaccine
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 605 participants
Where: 13 sitesItaly
Study dates: Oct 2006to Jul 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 75 to 105 days
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Aged 3 months (75 to 105 days) at time of enrollment.
Available for entire study period and whose parent(s)/legal guardian(s) could be reached by telephone.
Healthy infant, as determined by medical history, physical examination, and judgment of the investigator.
Born at greater than 32 weeks gestational age and greater than 2000 grams. Regardless of gestational age and birth weight, all subjects must have met inclusion criterion number 3.
Parent(s)/legal guardian(s) had to be able to complete all relevant study procedures during study participation.

Who cannot join

Previous vaccination with licensed or investigational pneumococcal vaccine.
Previous vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, or hepatitis B vaccines.
A previous anaphylactic reaction to any vaccine or vaccine-related component.
Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, or hepatitis B, or pneumococcal vaccines.
Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
Known or suspected immune deficiency or suppression.

Show all 12Show fewer

History of culture-proven invasive disease caused by S pneumoniae or Hib.
Major known congenital malformation or serious chronic disorder.
Significant neurological disorder or history of seizure, including febrile seizure, or significant stable or evolving disorders, such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorders. Did not include resolving syndromes due to birth trauma such as Erb palsy.
Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies; eg, Synagis® [MedImmune]).
Participation in another investigational trial. Participation in purely observational studies was acceptable.
Infant who was a direct descendant (eg, child or grandchild) of the study site personnel.

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

Italy13 sites

Study site
Bologna, Emilia-Romagna, 40138
Study site
Florence, Tuscany, 50132
Study site
Genoa, Liguria, 16132
Study site
Milan, Lombardy, 20122
Study site
Naples, Campania, 80122
Study site
Naples, Campania, 80139
Study site
Novara, Piedmont, 28100
Study site
Palermo, Sicily, 90100
Study site
Ragusa, Sicily, 97100
Study site
Rome, Lazio, 00100
Study site
Rome, Lazio, 00165
Study site
Sassari, Sardinia, 07100
Study site
Taranto, Apulia, 74100

Other trials in Italy

About this study

Official title: A Phase 3, Randomized, Active-Controlled, Double-blind Trial Evaluating the Safety,Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Paediatric Vaccinations in Italy

Conditions: Vaccines, Pneumococcal
Being tested: 13-valent pneumococcal conjugate vaccine, 7 valent pneumococcal conjugate vaccine
Keywords: Vaccine, Infants

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

13-valent pneumococcal conjugate vaccineBiological
Single 0.5 mL dose of 13vPnC given at 3, 5 and 11 months of age.
7 valent pneumococcal conjugate vaccineBiological
Single 0.5 mL dose of 7vPnC given at 3, 5 and 11 months of age.

Study groups in NCT00366899
Study group	Role	What they receive
1	Experimental	13-valent pneumococcal conjugate vaccine Receives: Biological: 13-valent pneumococcal conjugate vaccine
2	Active comparator	7-valent pneumococcal conjugate vaccine Receives: Biological: 7 valent pneumococcal conjugate vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants Reporting Pre-Specified Local Reactions
Local reactions were collected 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 be represented in more than 1 category.
Measured: During the 4-day period after each dose
Percentage of Participants Reporting Pre-Specified Systemic Events
Systemic events (fever ≥ 37.5 degrees Celsius [C], fever ≥ 38 C but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased appetite, irritability, increased sleep, decreased sleep, hives, use of medication (meds) to treat symptoms, and use of medication to prevent symptoms) were reported using an electronic diary. Participants may be represented in more than 1 category.
Measured: During the 4-day period after each dose
Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose
Percentage of Participants achieving predefined antibody threshold levels for Pertussis Toxoid (PT) ≥5 ELISA units per milliliter (EU/mL), Filamentous Haemagglutinin (FHA) ≥5 or ≥7.82 EU/mL, and Pertactin (PRN) ≥5 EU/mL, ≥10.0 Milli-International Units Per Milliliter (mIU/mL) for Hepatitis B, Haemophilus Influenzae type b (Hib) 0.15 μg/ml, 0.01 or 0.1 IU/mL for Diphtheria, 0.1 IU/mL for Tetanus, and ≥1:8 titer for Polio (Type 1, 2, and 3) with the corresponding 95% CI for antigens are presented.
Measured: One month after the infant series (6 months of age) and after the toddler dose (12 months of age)
Geometric Mean Antibody Concentration (GMC) of Pertussis in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose
GMC of Pertussis (PT, FHA, PRN) were measured using an anti-Bordetella pertussis enzyme-linked immunosorbent assay (ELISA). Results were recorded in ELISA units per milliliter (EU/mL)
Measured: one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age)
Geometric Mean Antibody Concentration (GMC) for Hepatitis B in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After Toddler Dose
GMC of anti-hepatitis B surface antigen (HBsAg)using an Food and Drug Administration (FDA) approved in vitro diagnostic kit.
Measured: One month after the infant series (6 months of age) and the toddler dose (12 months of age)
Geometric Mean Antibody Concentration (GMC) of Haemophilus Influenzae Type b (Hib) in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose
GMC for Hib polyribosylribitol phosphate as measured by ELISA, expressed in micrograms per milliliter (μg/mL).
Measured: one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age)
Geometric Mean Antibody Concentration (GMC) of Diptheria and Tetanus in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose
GMC of anti-diphtheria and anti-tetanus toxoids as measured by ELISA (IU/mL).
Measured: one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age)
Geometric Mean Antibody Concentration (GMC) of Polio Types 1, 2, and 3 in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose
GMC of Polio as measured using a polio in vitro plaque neutralization.
Measured: one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age)
Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Group After the 2-Dose Infant Series and Before the Toddler Dose
Percentages 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.
Measured: one month after infant series dose 2 (6 months of age) and before the toddler dose (11 months of age)
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the 2-Dose Infant Series and Before 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) are presented.
Measured: One month after infant series dose 2 (6 months of age) and before the toddler dose (11 months of age)

Secondary outcomes (2)

Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Relative to the 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.
Measured: One month after the toddler dose (12 months of age)
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Relative to 7vPnC Group After the 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) are presented.
Measured: One month after toddler dose (12 months of age)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2006Jul 2008

First posted21 Aug 2006 (estimated)
Study startOct 2006
Primary completionJul 2008
Study completionJul 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Vaccines, PneumococcalStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 605 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00366899
Sponsor's protocol ID: 6096A1-500
Status last verified: Jan 2013
First submitted: 17 Aug 2006
Last updated: 22 Feb 2013
Results posted: Yes, on ClinicalTrials.gov

Publications

Rodgers GL, Esposito S, Principi N, Gutierrez-Brito M, Diez-Domingo J, Pollard AJ, Snape MD, Martinon-Torres F, Gruber WC, Patterson S, Thompson A, Gurtman A, Paradiso P, Scott DA. Immune response to 13-valent pneumococcal conjugate vaccine with a reduced dosing schedule. Vaccine. 2013 Oct 1;31(42):4765-74. doi: 10.1016/j.vaccine.2013.08.009. Epub 2013 Aug 16.
PubMed 23965217

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Vaccines, Pneumococcal trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Randomized, Active-Controlled, Double-blind Trial Evaluating the Safety,Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Paediatric Vaccinations in Italy
ClinicalTrials.gov ID: NCT00366899
Acronym / sponsor ID: 6096A1-500
Conditions: Vaccines, Pneumococcal
Keywords: Vaccine, Infants
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 605 participants (actual)
Lead sponsor: Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
Study start: Oct 2006
Primary completion: Jul 2008 (actual)
Study completion: Jul 2008 (actual)
First posted: 21 Aug 2006 (estimated)
Results: Posted 22 Feb 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Biological: 13-valent pneumococcal conjugate vaccine13-valent pneumococcal conjugate vaccine
2	Active comparator	Biological: 7 valent pneumococcal conjugate vaccine7-valent pneumococcal conjugate vaccine

Who may qualify

Ages: 75 to 105 days
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (5 listed)

Aged 3 months (75 to 105 days) at time of enrollment.
Available for entire study period and whose parent(s)/legal guardian(s) could be reached by telephone.
Healthy infant, as determined by medical history, physical examination, and judgment of the investigator.
Born at greater than 32 weeks gestational age and greater than 2000 grams. Regardless of gestational age and birth weight, all subjects must have met inclusion criterion number 3.
Parent(s)/legal guardian(s) had to be able to complete all relevant study procedures during study participation.

Key exclusion criteria (12 listed)

Previous vaccination with licensed or investigational pneumococcal vaccine.
Previous vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, or hepatitis B vaccines.
A previous anaphylactic reaction to any vaccine or vaccine-related component.
Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, or hepatitis B, or pneumococcal vaccines.
Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
13-valent pneumococcal conjugate vaccineSingle 0.5 mL dose of 13vPnC given at 3, 5 and 11 months of age.	Biological	1
7 valent pneumococcal conjugate vaccineSingle 0.5 mL dose of 7vPnC given at 3, 5 and 11 months of age.	Biological	2

Primary outcome

Percentage of Participants Reporting Pre-Specified Local Reactions
Time frame: During the 4-day period after each dose
Local reactions were collected 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 be represented in more than 1 category.
Percentage of Participants Reporting Pre-Specified Systemic Events
Time frame: During the 4-day period after each dose
Systemic events (fever ≥ 37.5 degrees Celsius [C], fever ≥ 38 C but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased appetite, irritability, increased sleep, decreased sleep, hives, use of medication (meds) to treat symptoms, and use of medication to prevent symptoms) were reported using an electronic diary. Participants may be represented in more than 1 category.
Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose
Time frame: One month after the infant series (6 months of age) and after the toddler dose (12 months of age)
Percentage of Participants achieving predefined antibody threshold levels for Pertussis Toxoid (PT) ≥5 ELISA units per milliliter (EU/mL), Filamentous Haemagglutinin (FHA) ≥5 or ≥7.82 EU/mL, and Pertactin (PRN) ≥5 EU/mL, ≥10.0 Milli-International Units Per Milliliter (mIU/mL) for Hepatitis B, Haemophilus Influenzae type b (Hib) 0.15 μg/ml, 0.01 or 0.1 IU/mL for Diphtheria, 0.1 IU/mL for Tetanus, and ≥1:8 titer for Polio (Type 1, 2, and 3) with the corresponding 95% CI for antigens are presented.
Geometric Mean Antibody Concentration (GMC) of Pertussis in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose
Time frame: one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age)
GMC of Pertussis (PT, FHA, PRN) were measured using an anti-Bordetella pertussis enzyme-linked immunosorbent assay (ELISA). Results were recorded in ELISA units per milliliter (EU/mL)
Geometric Mean Antibody Concentration (GMC) for Hepatitis B in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After Toddler Dose
Time frame: One month after the infant series (6 months of age) and the toddler dose (12 months of age)
GMC of anti-hepatitis B surface antigen (HBsAg)using an Food and Drug Administration (FDA) approved in vitro diagnostic kit.
Geometric Mean Antibody Concentration (GMC) of Haemophilus Influenzae Type b (Hib) in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose
Time frame: one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age)
GMC for Hib polyribosylribitol phosphate as measured by ELISA, expressed in micrograms per milliliter (μg/mL).
Geometric Mean Antibody Concentration (GMC) of Diptheria and Tetanus in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose
Time frame: one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age)
GMC of anti-diphtheria and anti-tetanus toxoids as measured by ELISA (IU/mL).
Geometric Mean Antibody Concentration (GMC) of Polio Types 1, 2, and 3 in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose
Time frame: one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age)
GMC of Polio as measured using a polio in vitro plaque neutralization.
Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Group After the 2-Dose Infant Series and Before the Toddler Dose
Time frame: one month after infant series dose 2 (6 months of age) and before the toddler dose (11 months of age)
Percentages 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.
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the 2-Dose Infant Series and Before Toddler Dose
Time frame: One month after infant series dose 2 (6 months of age) and before the toddler dose (11 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) are presented.

2 secondary outcomes

Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Relative to the 7vPnC Group After the Toddler Dose
Time frame: One month after the toddler dose (12 months of age)
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Relative to 7vPnC Group After the Toddler Dose
Time frame: One month after toddler dose (12 months of age)

Results and safety

Results posted to the registry on 22 Feb 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
13vPnC	303	294
7vPnC	303	291

Primary outcome: Percentage of Participants Reporting Pre-Specified Local Reactions

Time frame: During the 4-day period after each dose. Number. Unit: Percentage of Participants

Measure	13vPnC Dose 1 n = 302	7vPnC Dose 1 n = 302	13vPnC Dose 2 n = 296	7vPnC Dose 2 n = 293	13vPnC Toddler Dose n = 294	7vPnC Toddler Dose n = 291
Tenderness - Any (n=234,243,214,215,199,188)	32.1	30.0	30.4	36.7	47.2	44.1
Tenderness-Significant (n=224,231,199,199,164,153)	2.7	3.5	4.5	5.0	8.5	5.9
Swelling - Any (n=232,240,207,209,175,165)	19.0	19.6	24.6	28.7	28.6	27.3
Swelling - Mild (n=232,240,207,208,174,161)	17.7	18.3	21.7	26.4	26.4	21.7
Swelling - Moderate (n=223,229,198,195,160,157)	3.6	3.1	5.6	5.1	7.5	10.2
Swelling - Severe (n=222,229,197,194,159,152)	0.0	0.0	0.0	0.0	0.0	0.0
Redness - Any (n=233,245,213,212,178,174)	25.8	26.5	31.5	34.4	36.5	36.2
Redness - Mild (n=233,244,211,211,178,172)	24.0	24.6	28.4	32.2	32.6	30.8

Population analysed: The safety population included all participants who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.

Primary outcome: Percentage of Participants Reporting Pre-Specified Systemic Events

Time frame: During the 4-day period after each dose. Number. Unit: Percentage of Participants

Measure	13vPnC Dose 1 n = 302	7vPnC Dose 1 n = 302	13vPnC Dose 2 n = 296	7vPnC Dose 2 n = 293	13vPnC Toddler Dose n = 294	7vPnC Toddler Dose n = 291
Fever ≥38°C but ≤39°C (n=247,246,227,226,204,197)	41.7	38.6	55.5	60.6	63.7	52.3
Fever >39°C but ≤40°C (n=224,233,204,201,167,160)	3.6	4.7	6.9	7.0	9.6	12.5
Fever >40°C (n=222,230,198,195,160,152)	0.0	0.0	0.0	0.0	0.0	0.7
Decreased appetite (n=246,248,220,218,198,197)	35.4	34.3	47.3	45.4	52.0	57.4
Irritability (n=258,259,245,243,221,227)	72.9	63.7	75.5	75.3	74.7	74.9
Increased sleep (n=269,276,226,232,195,196)	65.8	64.5	57.1	56.5	53.8	54.6
Decreased sleep (n=244,242,222,213,180,171)	39.3	36.4	40.1	41.8	35.6	35.7
Meds-treat symptoms (n=244,245,219,109,192,190)	34.8	30.6	43.4	47.8	53.1	43.7

Population analysed: The safety population included all subjects who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.

Primary outcome: Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose

Time frame: One month after the infant series (6 months of age) and after the toddler dose (12 months of age). Number (95% Confidence Interval). Unit: percentage of participants

Measure	13vPnC After 2-Dose Infant Series n = 275	7vPnC After 2-Dose Infant Series n = 279	13vPnC After Toddler Dose n = 254	7vPnC After Toddler Dose n = 261
Pertussis, PT ≥5 EU/mL (n=250,272,235,219)	99.6 (97.8 to 100.0)	100.0 (98.7 to 100.0)	100.0 (98.4 to 100.0)	100.0 (98.3 to 100.0)
Pertussis, FHA ≥5 EU/mL (n=243,272,229,214)	100.0 (98.5 to 100.0)	100.0 (98.7 to 100.0)	100.0 (98.4 to 100.0)	100.0 (98.3 to 100.0)
Pertussis, FHA ≥7.82 EU/mL (n=243,272,229,214)	100.0 (98.5 to 100.0)	100.0 (98.7 to 100.0)	100.0 (98.4 to 100.0)	100.0 (98.3 to 100.0)
Pertactin ≥5 EU/mL (n=248,270,234,217)	100.0 (98.5 to 100.0)	100.0 (98.6 to 100.0)	100.0 (98.4 to 100.0)	100.0 (98.3 to 100.0)
Hepatitis B ≥ 10.0 mIU/mL	93.8 (90.2 to 96.3)	93.1 (89.5 to 95.8)	98.40 (96.00 to 99.60)	98.80 (96.60 to 99.80)
Haemophilus Influenzae type b 0.15 μg/ml	87.0 (82.0 to 91.1)	90.3 (86.1 to 93.5)	99.6 (97.7 to 100.0)	98.2 (95.4 to 99.5)
Haemophilus Influenzae type b 1.0 μg/ml	49.9 (42.7 to 56.0)	48.7 (42.6 to 54.9)	96.2 (92.9 to 98.2)	92.2 (87.8 to 95.4)
Diptheria 0.01 IU/mL (n=207,240,164,190)	100.0 (98.2 to 100.0)	100.0 (98.5 to 100.0)	100.0 (97.8 to 100.0)	100.0 (98.1 to 100.0)

13vPnC After 2-Dose Infant Series vs 7vPnC After 2-Dose Infant Series: Difference: -0.4 (95% CI -2.2 to 1.0)
13vPnC After 2-Dose Infant Series vs 7vPnC After 2-Dose Infant Series: Difference: 0.0 (95% CI -4.0 to 3.8)
13vPnC After 2-Dose Infant Series vs 7vPnC After 2-Dose Infant Series: Difference: 0.0 (95% CI -1.6 to 1.4)

Primary outcome: Geometric Mean Antibody Concentration (GMC) of Pertussis in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose

Time frame: one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age). Geometric mean (95% Confidence Interval). Unit: EU/mL

Measure	13vPnC After 2-Dose Infant Series n = 275	7vPnC After 2-Dose Infant Series n = 279	13vPnC After Toddler Dose n = 254	7vPnC After Toddler Dose n = 261
Pertussis FHA	102.87 (94.35 to 112.16)	105.17 (97.25 to 113.73)	463.23 (425.19 to 504.67)	456.55 (415.06 to 502.18)
Pertussis PT	50.01 (45.82 to 54.58)	48.44 (44.71 to 52.49)	60.89 (55.61 to 66.67)	64.53 (59.13 to 70.42)
Pertussis PRN	167.76 (149.54 to 188.18)	166.19 (150.28 to 183.78)	339.30 (309.16 to 372.38)	361.70 (328.59 to 398.14)

13vPnC After 2-Dose Infant Series vs 7vPnC After 2-Dose Infant Series: Ratio: 0.98 (95% CI 0.87 to 1.10)
13vPnC After 2-Dose Infant Series vs 7vPnC After 2-Dose Infant Series: Ratio: 1.03 (95% CI 0.92 to 1.16)
13vPnC After 2-Dose Infant Series vs 7vPnC After 2-Dose Infant Series: Ratio: 1.01 (95% CI 0.87 to 1.17)

Population analysed: Evaluable immunogenicity (per protocol) population adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
13vPnC Infant Series	6 of 303 (2%)	188 of 303 (62%)	Not reported
7vPnC Infant Series	10 of 303 (3.3%)	183 of 303 (60.4%)	Not reported
13vPnC Post-Infant Series	8 of 294 (2.7%)	96 of 294 (32.7%)	Not reported
7vPnC Post-Infant Series	11 of 291 (3.8%)	90 of 291 (30.9%)	Not reported
13vPnC Toddler Series	3 of 287 (1%)	165 of 287 (57.5%)	Not reported
7vPnC Toddler Series	1 of 282 (0.4%)	170 of 282 (60.3%)	Not reported
13vPnC 6-Month Follow-up	9 of 290 (3.1%)	1 of 290 (0.3%)	Not reported
7vPnC 6-Month Follow-up	11 of 288 (3.8%)	0 of 288 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23965217Rodgers GL, Esposito S, Principi N, Gutierrez-Brito M, Diez-Domingo J, Pollard AJ, Snape MD, Martinon-Torres F, Gruber WC, Patterson S, Thompson A, Gurtman A, Paradiso P, Scott DA. Immune response to 13-valent pneumococcal conjugate vaccine with a reduced dosing schedule. Vaccine. 2013 Oct 1;31(42):4765-74. doi: 10.1016/j.vaccine.2013.08.009. Epub 2013 Aug 16.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Monitor study director

Wyeth is now a wholly owned subsidiary of Pfizer

Trial Manager principal investigator

For Italy, descresg@wyeth.com

13 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Reporting Pre-Specified Local Reactions (time frame: During the 4-day period after each dose). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00366899, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2013.