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Local Indian (Primed group) ICF Version 1.0, dated 30/JUL/2009 based on Model ICF Version 01 (Primed group), dated 22/APR/2009
Your child/ward completed the full vaccination course with the 10Pn-PD-DiT vaccine in study 10PN-PD-DIT-037 (111188) according to a 3-dose primary vaccination at 6, 10 and 14 weeks of age.
Your child/ward will belong to one of the 2 primed groups and will receive the booster dose of the 10Pn-PD-DiT vaccine at either 9-12 months of age or 15-18 months of age.
In addition, your child/ward can also receive other licensed vaccines according to the national recommended vaccination program including vaccination with a measles-containing vaccine and a combined diphtheria-tetanus-acellular pertussis and Hib (DTPa/Hib) vaccine.
The measles-containing vaccine will be administered together with the booster dose of the 10Pn-PD-DiT vaccine for children who belong to the Pn-Pn9 group. The DTPa/Hib vaccine will be administered together with the booster dose of the 10Pn-PD-DiT vaccine for children who belong to the Pn-Pn15 group.
• Male or female subjects who have completed the full vaccination course with the 10Pn-PD-DiT vaccine in study 10PN-PD-DIT-037 (111188).
• 9-12 months of age at the time of randomization.
• 9-12 months of age at the time of booster vaccination for the Pn-Pn9 group.
• 15-18 months of age at the time of booster vaccination for the Pn-Pn15 group.
If you agree for your child/ward to take part in the study, your child/ward will be required to attend the clinic on 3 occasions. The duration of your child’s/ward’s participation in this study will be approximately 15 months if your child/ward belongs to the Pn-Pn9 group and approximately 9 months in case your child/ward belongs to the Pn-Pn15 group. The table below shows what will happen at each study visit.
The 10Pn-PD-DiT vaccine will be administered as an injection in the muscle tissue of the right or left thigh. The measles-containing vaccine in group Pn-Pn9 and the DTPa/Hib vaccine in group Pn-Pn15 are to be administered in the muscle tissue of the opposite thigh. If your child/ward is ill at the vaccination visit, the vaccination can be rescheduled.
Blood samples will be taken from a vein in the amount of about 1 teaspoonful (approximately 3.5 milliliters) at each visit (Visit 1, Visit 2 and Visit 3). The blood samples taken will be used to perform analysis in terms of response (amount and activity of antibodies) all primed children have to the 10Pn-PD-DiT vaccine following vaccination in the previous vaccination study 10PN-PD-DIT-037 (111188) and following booster vaccination in the present study. Blood draws may cause momentary discomfort, minor bruising or bleeding. The blood amount to be taken will not be harmful to your child’s/ward’s health.
After vaccination at Visit 1, you will be given diary cards and instructions to record the information as presented in the table below:
The completed diary cards have to be returned at Visit 2.
• to return to the clinic at scheduled visits (3 visits in total) and to answer questions at each study visit,
• to return the completed diary cards at Visit 2,
• The opportunity to boost your child/ward against a major cause of infectious diseases common in India such as by Streptococcus pneumoniae and Haemophilus influenzae.
• confirm that I have read the written information (or have had the information read to me) for study 112909 (10PN-PD-DIT-062 BST:037) Local Indian (Primed groups) ICF Version 1.0, dated 30/JUL/2009, based on the Model ICF Version 01 (Primed groups), dated 22/APR/2009, 11 pages, and the study procedures have been explained to me by study staff during the consent process for this study,
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